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BECKMAN COULTER, INC. FDA Inspection Record

FEI 3000203293 · Inspections, Form 483s, warning letters and import refusals

BECKMAN COULTER, INC. is an FDA-registered facility (FEI 3000203293) located in Miami, FL, US. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Oct 28, 2021: Voluntary Action Indicated (VAI)
Inspections on record
4 (1 OAI, 2 VAI, 1 NAI)
Last OAI inspection
Jun 2, 2011
Warning letters
1 listed by FDA for this FEI, latest Nov 1, 2011
Recalls as the recalling firm
13, latest Aug 12, 2026
Import refusals
1

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
Oct 28, 2021Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Individual Report of Malfunction (21 CFR 803.50(a)(2))
Oct 16, 2017Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Investigation of device failures (21 CFR 820.198(c))
Servicing - Lack of or inadequate procedures (21 CFR 820.200(a))
Lack of Written MDR Procedures (21 CFR 803.17)
Sep 11, 2013No Action Indicated (NAI)No citations listed
Jun 2, 2011Official Action Indicated (OAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Procedures not adequately established or maintained (21 CFR 820.40)
Training - Lack of or inadequate procedures (21 CFR 820.25(b))
Design validation- Lack of or inadequate procedures (21 CFR 820.30(g))
and 3 more

Recalls

Showing the 10 most recent of 13 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
Aug 12, 2026Class IIZ-0160-2027DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513 and 1 more product
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid…
Dec 23, 2025Class IIZ-1235-2026CellMek SPS Sample Preparation System, REF: C44603, with software
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close…
Nov 10, 2025Class IIZ-1221-2026COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an…
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Sep 8, 2025Class IIZ-0412-2026CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior…
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect…
Jul 16, 2024Class IIIZ-0093-2025Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and…
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure…
Dec 19, 2023Class IIZ-0784-2024Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947 and 3 more products
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust…
May 31, 2023Class IIZ-2138-2023COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Apr 5, 2023Class IIZ-1596-2023iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and… and 3 more products
Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not…
Nov 18, 2022Class IIZ-0777-2023BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive…
Feb 16, 2022Class IIIZ-0984-2022Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles…
IRISpec CA failures for glucose.

FDA record score

32 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. Each record below adds the points shown.

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.

15 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-0160-2027, this FEI as the recalling firmAug 12, 20264 x 14
Class II recall Z-1235-2026, this FEI as the recalling firmDec 23, 20254 x 14
Class II recall Z-1221-2026, this FEI as the recalling firmNov 10, 20254 x 14
Class II recall Z-0412-2026, this FEI as the recalling firmSep 8, 20254 x 14
Class II recall Z-0784-2024, this FEI as the recalling firmDec 19, 20234 x 0.62.4
Class II recall Z-2138-2023, this FEI as the recalling firmMay 31, 20234 x 0.62.4
Class II recall Z-1596-2023, this FEI as the recalling firmApr 5, 20234 x 0.62.4
Class II recall Z-0777-2023, this FEI as the recalling firmNov 18, 20224 x 0.62.4
Inspection classified VAIOct 28, 20216 x 0.251.5
Inspection classified VAIOct 16, 20176 x 0.251.5
Class II recall Z-2241-2021, this FEI as the recalling firmJun 23, 20214 x 0.251
Class II recall Z-1535-2020, this FEI as the recalling firmFeb 17, 20204 x 0.251
Class II recall Z-0516-2020, this FEI as the recalling firmOct 7, 20194 x 0.251
Warning letter on FDA's dashboard, which does not show close-outsNov 1, 201110 years or older, so it adds no points0
Inspection classified OAIJun 2, 201110 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
Miami, FL (US)
Source
device

Compliance actions

Import refusals

FDA data resources

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