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INSTRUMENTATION LABORATORY CO. FDA Inspection Record

FEI 1217183 · Inspections, Form 483s, warning letters and import refusals

INSTRUMENTATION LABORATORY CO. is an FDA-registered facility (FEI 1217183) located in Bedford, MA, US. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jul 12, 2013: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
25, latest Sep 3, 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
Jul 12, 2013Voluntary Action Indicated (VAI)No citations listed
Aug 24, 2011Voluntary Action Indicated (VAI)Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b))
Supplier notification of changes (21 CFR 820.50(b))
Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))
Evaluation of suppliers, contractors, etc., requirements (21 CFR 820.50(a))
and 1 more

Recalls

Showing the 10 most recent of 25 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 3, 2026Class IZ-0001-2027HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic and 1 more product
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
May 21, 2026Class IIZ-2899-2026GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 000… and 1 more product
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established…
May 8, 2026Class IIZ-2821-2026GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with… and 5 more products
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an…
Jan 20, 2026Class IIZ-1524-2026GEM Premier 5000 PAK, Part No. 00055360004. and 19 more products
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of…
Dec 11, 2025Class IIZ-1095-2026The product is used for the evaluation of the intrinsic coagulation pathway, APTT…
Potential for microbial contamination.
Nov 18, 2025Class IIIZ-0938-2026HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Recalled lots were manufactured with double the amount of preservative concentration.
Feb 3, 2025Class IIZ-2323-2025HemosIL LMW Heparin Controls; Part Number: 0020300200;
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of…
Dec 18, 2024Class IIZ-1020-2025HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package…
Sep 29, 2023Class IIZ-0357-2024GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004… and 2 more products
Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the…
Jul 13, 2023Class IIZ-2578-2023ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the…
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

FDA record score

56 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.

26 records behind this number
RecordDatePoints x age weightAdds
Class I recall Z-0001-2027, this FEI as the recalling firmSep 3, 202615 x 115
Class II recall Z-2899-2026, this FEI as the recalling firmMay 21, 20264 x 14
Class II recall Z-2821-2026, this FEI as the recalling firmMay 8, 20264 x 14
Class II recall Z-1524-2026, this FEI as the recalling firmJan 20, 20264 x 14
Class II recall Z-1095-2026, this FEI as the recalling firmDec 11, 20254 x 14
Class II recall Z-2323-2025, this FEI as the recalling firmFeb 3, 20254 x 14
Class II recall Z-1020-2025, this FEI as the recalling firmDec 18, 20244 x 14
Class II recall Z-0357-2024, this FEI as the recalling firmSep 29, 20234 x 0.62.4
Class II recall Z-2578-2023, this FEI as the recalling firmJul 13, 20234 x 0.62.4
Class II recall Z-1304-2023, this FEI as the recalling firmFeb 3, 20234 x 0.62.4
Class II recall Z-1052-2022, this FEI as the recalling firmApr 8, 20224 x 0.62.4
Class II recall Z-1014-2022, this FEI as the recalling firmFeb 22, 20224 x 0.62.4
Class II recall Z-0276-2022, this FEI as the recalling firmOct 13, 20214 x 0.251
Class II recall Z-0149-2022, this FEI as the recalling firmAug 25, 20214 x 0.251
Class II recall Z-2485-2019, this FEI as the recalling firmJul 23, 20194 x 0.251
Class II recall Z-0077-2019, this FEI as the recalling firmAug 1, 20184 x 0.251
Class II recall Z-0895-2018, this FEI as the recalling firmAug 2, 20174 x 0.251
Class II recall Z-0736-2016, this FEI as the recalling firmDec 18, 201510 years or older, so it adds no points0
Class II recall Z-0832-2015, this FEI as the recalling firmNov 21, 201410 years or older, so it adds no points0
Class II recall Z-2060-2014, this FEI as the recalling firmJun 3, 201410 years or older, so it adds no points0
Class II recall Z-0514-2014, this FEI as the recalling firmNov 15, 201310 years or older, so it adds no points0
Class II recall Z-2244-2013, this FEI as the recalling firmJul 19, 201310 years or older, so it adds no points0
Inspection classified VAIJul 12, 201310 years or older, so it adds no points0
Class II recall Z-1784-2013, this FEI as the recalling firmApr 9, 201310 years or older, so it adds no points0
Class II recall Z-2387-2012, this FEI as the recalling firmAug 3, 201210 years or older, so it adds no points0
Inspection classified VAIAug 24, 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 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Instrumentation Laboratory
Location
Bedford, MA (US)
Source
device

Import refusals

FDA data resources

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