Instrumentation Laboratory recalls
25 recalls in our records from 2012 to 2026: 25 FDA medical devices.
Recalls with full detail pages
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Instrumentation Laboratory medical device recall: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro…
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Earlier and other recalls
These link to the official agency notice.
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Instrumentation Laboratory medical device recall: GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510… Official notice ↗
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The…
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Instrumentation Laboratory medical device recall: GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM… Official notice ↗
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
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Instrumentation Laboratory medical device recall: GEM Premier 5000 PAK Official notice ↗
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not…
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Instrumentation Laboratory medical device recall: The product is used for the evaluation of the intrinsic coagulation… Official notice ↗
Potential for microbial contamination.
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Instrumentation Laboratory medical device recall: HemosIL SynthAFax. Partial Thromboplastin Time Tests Official notice ↗
Recalled lots were manufactured with double the amount of preservative concentration.
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Instrumentation Laboratory medical device recall: HemosIL LMW Heparin Controls Official notice ↗
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance…
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Instrumentation Laboratory medical device recall: HemosIL Heparin Calibrators Official notice ↗
Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
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Instrumentation Laboratory medical device recall: GEM Premier 3000 PAK - pH Official notice ↗
Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less…
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Instrumentation Laboratory medical device recall: ACL TOP Family 50 Series Models as follows: In vitro diagnostic… Official notice ↗
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
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Instrumentation Laboratory medical device recall: ACL ELITE- Analyzer designed specifically for clinical use in the… Official notice ↗
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
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Instrumentation Laboratory medical device recall: HemosIL ReadiPlasTin Official notice ↗
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time…
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Instrumentation Laboratory medical device recall: ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number… Official notice ↗
Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or…
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Instrumentation Laboratory medical device recall: HemosIL ReadiPlasTin Official notice ↗
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample…
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Instrumentation Laboratory medical device recall: HemosIL Liquid Anti-Xa- Automated chromogenic assay for the… Official notice ↗
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
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Instrumentation Laboratory Co. medical device recall: ROTEM ex-tem Official notice ↗
Prolonged clotting times
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Instrumentation Laboratory Co. medical device recall: Hemosll ReadiPlasTin Official notice ↗
There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
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Instrumentation Laboratory Co. medical device recall: Hemosll ReadiPlasTin Official notice ↗
Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of…
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Instrumentation Laboratory Co. medical device recall: HemosIL Plasminogen Official notice ↗
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
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Instrumentation Laboratory Co. medical device recall: HemosIL PT-Fibrinogen HS PLUS Official notice ↗
Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution…
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Instrumentation Laboratory Co. medical device recall: Acl Top Official notice ↗
Potential for sample misidentification.
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Instrumentation Laboratory Co. medical device recall: HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 Official notice ↗
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
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Instrumentation Laboratory Co. medical device recall: Acl Top Official notice ↗
Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
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Instrumentation Laboratory Co. medical device recall: HemosIL RecombiPlasTin 2G Official notice ↗
Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
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Instrumentation Laboratory Co. medical device recall: Instrumentation Laboratory ACL TOP Official notice ↗
Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.