BECKMAN COULTER, INC. FDA Inspection Record

FEI 2050012 · Inspections, Form 483s, warning letters and import refusals

BECKMAN COULTER, INC. is an FDA-registered facility (FEI 2050012) located in BREA, CA, US. RegDataLab tracks 7 FDA inspections and 2 compliance actions at this facility.

What FDA found at this site

Latest inspection
Aug 5, 2021: No Action Indicated (NAI)
Inspections on record
7 (1 OAI, 1 VAI, 5 NAI)
Last OAI inspection
May 12, 2011
Warning letters
2 listed by FDA for this FEI, latest Aug 1, 2011
Recalls as the recalling firm
156, latest Sep 2, 2026
Import refusals
2

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Aug 5, 2021No Action Indicated (NAI)No citations listed
Oct 30, 2019No Action Indicated (NAI)No citations listed
Jul 16, 2012No Action Indicated (NAI)No citations listed
May 12, 2011Official Action Indicated (OAI)No citations listed
Feb 8, 2011Voluntary Action Indicated (VAI)No citations listed
Dec 8, 2009No Action Indicated (NAI)No citations listed
Feb 19, 2009No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 156 recalls. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Sep 2, 2026Class IIZ-0083-2027DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No… and 1 more product
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user…
Jul 15, 2026Class IIZ-2973-2026Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower… and 1 more product
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those…
Jun 26, 2026Class IIZ-2888-2026REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the… and 1 more product
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility…
Sep 22, 2025Class IIZ-0541-2026DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX…
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may…
Sep 17, 2025Class IIZ-0441-2026SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot…
Sep 3, 2025Class IIZ-0071-2026SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx…
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date…
Aug 13, 2025Class IIZ-2572-2025UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB… and 3 more products
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white…
Aug 4, 2025Class IIZ-0032-2026DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i…
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA…
Jun 26, 2025Class IIZ-2264-2025UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference…
Jun 12, 2025Class IIZ-2152-2025Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of…
A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots…

FDA record score

100 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. The records below add up to 145.4; the score stops at 100.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

154 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-0083-2027, this FEI as the recalling firmSep 2, 20264 x 14
Class II recall Z-2973-2026, this FEI as the recalling firmJul 15, 20264 x 14
Class II recall Z-2888-2026, this FEI as the recalling firmJun 26, 20264 x 14
Class II recall Z-0541-2026, this FEI as the recalling firmSep 22, 20254 x 14
Class II recall Z-0441-2026, this FEI as the recalling firmSep 17, 20254 x 14
Class II recall Z-0071-2026, this FEI as the recalling firmSep 3, 20254 x 14
Class II recall Z-2572-2025, this FEI as the recalling firmAug 13, 20254 x 14
Class II recall Z-0032-2026, this FEI as the recalling firmAug 4, 20254 x 14
Class II recall Z-2264-2025, this FEI as the recalling firmJun 26, 20254 x 14
Class II recall Z-2152-2025, this FEI as the recalling firmJun 12, 20254 x 14
Class II recall Z-2028-2025, this FEI as the recalling firmApr 8, 20254 x 14
Class II recall Z-1784-2025, this FEI as the recalling firmMar 20, 20254 x 14
Class II recall Z-1672-2025, this FEI as the recalling firmMar 17, 20254 x 14
Class II recall Z-1517-2025, this FEI as the recalling firmFeb 26, 20254 x 14
Class II recall Z-1112-2025, this FEI as the recalling firmJan 2, 20254 x 14
Class I recall Z-1382-2019, this FEI as the recalling firmJul 30, 201815 x 0.253.8
Class I recall Z-0471-2019, this FEI as the recalling firmJan 12, 201815 x 0.253.8
Class II recall Z-0673-2025, this FEI as the recalling firmNov 8, 20244 x 0.62.4
Class II recall Z-0118-2025, this FEI as the recalling firmJul 31, 20244 x 0.62.4
Class II recall Z-2428-2024, this FEI as the recalling firmMay 27, 20244 x 0.62.4
Class II recall Z-2488-2023, this FEI as the recalling firmJul 12, 20234 x 0.62.4
Class II recall Z-1606-2023, this FEI as the recalling firmApr 5, 20234 x 0.62.4
Class II recall B-0337-2023, this FEI as the recalling firmNov 22, 20224 x 0.62.4
Class II recall Z-0692-2022, this FEI as the recalling firmDec 8, 20214 x 0.62.4
Class II recall Z-0399-2022, this FEI as the recalling firmNov 10, 20214 x 0.251
Class II recall Z-0032-2022, this FEI as the recalling firmAug 9, 20214 x 0.251
Class II recall Z-2508-2021, this FEI as the recalling firmAug 5, 20214 x 0.251
Class II recall Z-0117-2022, this FEI as the recalling firmJul 28, 20214 x 0.251
Class II recall Z-2602-2021, this FEI as the recalling firmJul 21, 20214 x 0.251
Class II recall Z-2332-2021, this FEI as the recalling firmJul 15, 20214 x 0.251
Class II recall Z-2255-2021, this FEI as the recalling firmJul 1, 20214 x 0.251
Class II recall Z-1905-2021, this FEI as the recalling firmMay 7, 20214 x 0.251
Class II recall Z-1670-2021, this FEI as the recalling firmApr 14, 20214 x 0.251
Class II recall Z-0875-2021, this FEI as the recalling firmDec 30, 20204 x 0.251
Class II recall Z-0720-2021, this FEI as the recalling firmDec 2, 20204 x 0.251
Class II recall Z-3006-2020, this FEI as the recalling firmAug 26, 20204 x 0.251
Class II recall Z-3028-2020, this FEI as the recalling firmAug 18, 20204 x 0.251
Class II recall Z-1944-2020, this FEI as the recalling firmMar 30, 20204 x 0.251
Class II recall Z-2136-2020, this FEI as the recalling firmJan 29, 20204 x 0.251
Class II recall Z-1673-2020, this FEI as the recalling firmJan 17, 20204 x 0.251
Class II recall Z-1674-2020, this FEI as the recalling firmDec 13, 20194 x 0.251
Class II recall Z-0843-2020, this FEI as the recalling firmNov 7, 20194 x 0.251
Class II recall Z-0913-2020, this FEI as the recalling firmOct 28, 20194 x 0.251
Class II recall Z-1083-2022, this FEI as the recalling firmOct 21, 20194 x 0.251
Class II recall Z-1370-2021, this FEI as the recalling firmSep 4, 20194 x 0.251
Class II recall Z-1751-2020, this FEI as the recalling firmSep 4, 20194 x 0.251
Class II recall Z-1799-2020, this FEI as the recalling firmJun 12, 20194 x 0.251
Class II recall Z-1741-2020, this FEI as the recalling firmMay 17, 20194 x 0.251
Class II recall Z-2237-2020, this FEI as the recalling firmApr 30, 20194 x 0.251
Class II recall Z-1077-2019, this FEI as the recalling firmDec 5, 20184 x 0.251
Class II recall Z-0492-2020, this FEI as the recalling firmNov 9, 20184 x 0.251
Class II recall Z-1937-2019, this FEI as the recalling firmOct 18, 20184 x 0.251
Class II recall Z-2763-2019, this FEI as the recalling firmSep 18, 20184 x 0.251
Class II recall Z-1982-2019, this FEI as the recalling firmSep 17, 20184 x 0.251
Class II recall Z-0210-2020, this FEI as the recalling firmAug 24, 20184 x 0.251
Class II recall Z-2599-2018, this FEI as the recalling firmMay 4, 20184 x 0.251
Class II recall Z-1894-2018, this FEI as the recalling firmMar 29, 20184 x 0.251
Class II recall Z-1804-2018, this FEI as the recalling firmMar 26, 20184 x 0.251
Class II recall Z-1362-2018, this FEI as the recalling firmMar 2, 20184 x 0.251
Class II recall Z-1643-2018, this FEI as the recalling firmMar 2, 20184 x 0.251
Class II recall Z-1341-2018, this FEI as the recalling firmJan 29, 20184 x 0.251
Class II recall Z-1169-2018, this FEI as the recalling firmJan 19, 20184 x 0.251
Class II recall Z-1151-2018, this FEI as the recalling firmJan 18, 20184 x 0.251
Class II recall Z-1893-2018, this FEI as the recalling firmDec 4, 20174 x 0.251
Class II recall Z-1366-2018, this FEI as the recalling firmNov 10, 20174 x 0.251
Class II recall Z-0236-2018, this FEI as the recalling firmNov 3, 20174 x 0.251
Class II recall Z-0091-2018, this FEI as the recalling firmOct 2, 20174 x 0.251
Class II recall Z-0605-2018, this FEI as the recalling firmAug 24, 20174 x 0.251
Class II recall Z-3135-2017, this FEI as the recalling firmAug 21, 20174 x 0.251
Class II recall Z-0046-2018, this FEI as the recalling firmAug 3, 20174 x 0.251
Class II recall Z-3118-2017, this FEI as the recalling firmJul 20, 20174 x 0.251
Class II recall Z-3113-2017, this FEI as the recalling firmJun 26, 20174 x 0.251
Class II recall Z-3101-2017, this FEI as the recalling firmJun 20, 20174 x 0.251
Class II recall Z-2689-2017, this FEI as the recalling firmMay 22, 20174 x 0.251
Class II recall Z-2635-2017, this FEI as the recalling firmMay 9, 20174 x 0.251
Class II recall Z-2124-2017, this FEI as the recalling firmApr 24, 20174 x 0.251
Class II recall Z-2157-2017, this FEI as the recalling firmApr 24, 20174 x 0.251
Class II recall Z-2074-2017, this FEI as the recalling firmApr 13, 20174 x 0.251
Class II recall Z-2035-2017, this FEI as the recalling firmApr 3, 20174 x 0.251
Class II recall Z-2078-2017, this FEI as the recalling firmApr 3, 20174 x 0.251
Class II recall Z-1833-2017, this FEI as the recalling firmMar 10, 20174 x 0.251
Class II recall Z-1709-2017, this FEI as the recalling firmMar 7, 20174 x 0.251
Class II recall Z-1704-2017, this FEI as the recalling firmFeb 13, 20174 x 0.251
Class II recall Z-1384-2017, this FEI as the recalling firmJan 30, 20174 x 0.251
Class II recall Z-1013-2017, this FEI as the recalling firmDec 19, 20164 x 0.251
Class II recall Z-0768-2017, this FEI as the recalling firmOct 25, 201610 years or older, so it adds no points0
Class II recall Z-0407-2017, this FEI as the recalling firmOct 24, 201610 years or older, so it adds no points0
Class II recall Z-0648-2017, this FEI as the recalling firmOct 19, 201610 years or older, so it adds no points0
Class II recall Z-2900-2016, this FEI as the recalling firmSep 6, 201610 years or older, so it adds no points0
Class II recall Z-2732-2016, this FEI as the recalling firmAug 8, 201610 years or older, so it adds no points0
Class II recall Z-2692-2016, this FEI as the recalling firmAug 4, 201610 years or older, so it adds no points0
Class II recall Z-2247-2016, this FEI as the recalling firmJun 27, 201610 years or older, so it adds no points0
Class II recall Z-2108-2016, this FEI as the recalling firmJun 8, 201610 years or older, so it adds no points0
Class II recall Z-1956-2016, this FEI as the recalling firmMay 17, 201610 years or older, so it adds no points0
Class II recall Z-1930-2016, this FEI as the recalling firmApr 13, 201610 years or older, so it adds no points0
Class II recall Z-1269-2016, this FEI as the recalling firmFeb 11, 201610 years or older, so it adds no points0
Class II recall Z-2274-2016, this FEI as the recalling firmFeb 5, 201610 years or older, so it adds no points0
Class II recall Z-1067-2016, this FEI as the recalling firmJan 13, 201610 years or older, so it adds no points0
Class II recall Z-0432-2016, this FEI as the recalling firmDec 1, 201510 years or older, so it adds no points0
Class II recall Z-0558-2016, this FEI as the recalling firmDec 1, 201510 years or older, so it adds no points0
Class II recall Z-0239-2016, this FEI as the recalling firmOct 13, 201510 years or older, so it adds no points0
Class II recall Z-0108-2016, this FEI as the recalling firmSep 10, 201510 years or older, so it adds no points0
Class II recall Z-0110-2016, this FEI as the recalling firmAug 31, 201510 years or older, so it adds no points0
Class II recall Z-2308-2016, this FEI as the recalling firmJul 30, 201510 years or older, so it adds no points0
Class II recall Z-2733-2015, this FEI as the recalling firmJul 28, 201510 years or older, so it adds no points0
Class II recall Z-2480-2015, this FEI as the recalling firmJul 22, 201510 years or older, so it adds no points0
Class II recall Z-2809-2015, this FEI as the recalling firmJul 17, 201510 years or older, so it adds no points0
Class II recall Z-1616-2015, this FEI as the recalling firmApr 13, 201510 years or older, so it adds no points0
Class II recall Z-1023-2015, this FEI as the recalling firmDec 15, 201410 years or older, so it adds no points0
Class II recall Z-0649-2016, this FEI as the recalling firmDec 8, 201410 years or older, so it adds no points0
Class II recall Z-0175-2015, this FEI as the recalling firmOct 6, 201410 years or older, so it adds no points0
Class II recall Z-2651-2014, this FEI as the recalling firmAug 25, 201410 years or older, so it adds no points0
Class II recall Z-2687-2014, this FEI as the recalling firmAug 21, 201410 years or older, so it adds no points0
Class II recall Z-1737-2014, this FEI as the recalling firmMay 14, 201410 years or older, so it adds no points0
Class II recall Z-2272-2016, this FEI as the recalling firmApr 22, 201410 years or older, so it adds no points0
Class II recall Z-0984-2014, this FEI as the recalling firmNov 26, 201310 years or older, so it adds no points0
Class II recall Z-0470-2014, this FEI as the recalling firmNov 8, 201310 years or older, so it adds no points0
Class II recall Z-1828-2014, this FEI as the recalling firmNov 8, 201310 years or older, so it adds no points0
Class II recall Z-0519-2014, this FEI as the recalling firmOct 2, 201310 years or older, so it adds no points0
Class II recall Z-0113-2014, this FEI as the recalling firmSep 24, 201310 years or older, so it adds no points0
Class II recall Z-0147-2014, this FEI as the recalling firmSep 24, 201310 years or older, so it adds no points0
Class II recall Z-0291-2014, this FEI as the recalling firmSep 12, 201310 years or older, so it adds no points0
Class II recall Z-0152-2014, this FEI as the recalling firmSep 9, 201310 years or older, so it adds no points0
Class II recall Z-1997-2013, this FEI as the recalling firmJul 17, 201310 years or older, so it adds no points0
Class II recall Z-1834-2013, this FEI as the recalling firmJun 3, 201310 years or older, so it adds no points0
Class II recall Z-1613-2013, this FEI as the recalling firmMay 28, 201310 years or older, so it adds no points0
Class II recall Z-1430-2013, this FEI as the recalling firmApr 26, 201310 years or older, so it adds no points0
Class II recall Z-1400-2013, this FEI as the recalling firmApr 17, 201310 years or older, so it adds no points0
Class II recall Z-1167-2013, this FEI as the recalling firmMar 20, 201310 years or older, so it adds no points0
Class II recall Z-1032-2013, this FEI as the recalling firmFeb 12, 201310 years or older, so it adds no points0
Class II recall Z-0958-2013, this FEI as the recalling firmDec 28, 201210 years or older, so it adds no points0
Class II recall Z-0913-2013, this FEI as the recalling firmNov 28, 201210 years or older, so it adds no points0
Class II recall Z-0572-2013, this FEI as the recalling firmNov 5, 201210 years or older, so it adds no points0
Class II recall Z-0612-2013, this FEI as the recalling firmNov 1, 201210 years or older, so it adds no points0
Class II recall Z-1873-2013, this FEI as the recalling firmOct 26, 201210 years or older, so it adds no points0
Class II recall Z-0123-2013, this FEI as the recalling firmSep 3, 201210 years or older, so it adds no points0
Class II recall Z-0046-2013, this FEI as the recalling firmJul 24, 201210 years or older, so it adds no points0
Class II recall Z-0059-2013, this FEI as the recalling firmJul 6, 201210 years or older, so it adds no points0
Class II recall Z-0033-2013, this FEI as the recalling firmMay 22, 201210 years or older, so it adds no points0
Class II recall Z-0056-2013, this FEI as the recalling firmApr 11, 201210 years or older, so it adds no points0
Class II recall Z-0021-2013, this FEI as the recalling firmApr 3, 201210 years or older, so it adds no points0
Class II recall Z-0003-2013, this FEI as the recalling firmJan 27, 201210 years or older, so it adds no points0
Class II recall Z-0002-2013, this FEI as the recalling firmJan 20, 201210 years or older, so it adds no points0
Class II recall Z-0016-2013, this FEI as the recalling firmJan 20, 201210 years or older, so it adds no points0
Class II recall Z-2225-2012, this FEI as the recalling firmDec 13, 201110 years or older, so it adds no points0
Class II recall Z-2257-2012, this FEI as the recalling firmOct 13, 201110 years or older, so it adds no points0
Class II recall Z-0345-2013, this FEI as the recalling firmAug 1, 201110 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsAug 1, 201110 years or older, so it adds no points0
Class II recall Z-0613-2013, this FEI as the recalling firmJul 27, 201110 years or older, so it adds no points0
Inspection classified OAIMay 12, 201110 years or older, so it adds no points0
Inspection classified VAIFeb 8, 201110 years or older, so it adds no points0
Class II recall Z-1951-2013, this FEI as the recalling firmSep 22, 201010 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsJun 21, 201010 years or older, so it adds no points0
Class II recall B-1738-5, this FEI as the recalling firmFeb 24, 200510 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Beckman Coulter Inc.
Location
BREA, CA (US)
Source
device

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.