Recall archive
24 recalls · page 1 of 1
Reported Aug 12, 2026
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand · Product details — The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2026
GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand — 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…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 18, 2026
GEM Premier 5000 PAK, Part No. 00055360004.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
19 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 21, 2026
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand — Potential for microbial contamination.
FDA (openFDA device enforcement)
Reported Dec 24, 2025
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Instrumentation Laboratory
Matched: Brand — Recalled lots were manufactured with double the amount of preservative concentration.
FDA (openFDA device enforcement)
Reported Aug 20, 2025
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand — Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the…
FDA (openFDA device enforcement)
Reported Feb 5, 2025
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand — Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert…
FDA (openFDA device enforcement)
Reported Nov 29, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 20, 2023
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand · Product · Product details — Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
FDA (openFDA device enforcement)
Reported Apr 5, 2023
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand · Product · Product details — Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 18, 2022
HemosIL ReadiPlasTin, Part No. 0020301400
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand — Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an…
FDA (openFDA device enforcement)
Reported May 4, 2022
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand — Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin,…
FDA (openFDA device enforcement)
Reported Dec 1, 2021
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand — The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls,…
FDA (openFDA device enforcement)
Reported Oct 27, 2021
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory
Matched: Brand — Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2019
ROTEM ex-tem; US Part No: 503-05-US
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory Co.
Matched: Brand — Prolonged clotting times
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 17, 2018
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory Co.
Matched: Brand — There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
FDA (openFDA device enforcement)
Reported Mar 14, 2018
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory Co.
Matched: Brand · Reason for recall — Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased…
FDA (openFDA device enforcement)
Reported Feb 10, 2016
HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory Co.
Matched: Brand · Product · Product details — This Lot is not meeting labeled on-board instrument stability claims of 5 days.
FDA (openFDA device enforcement)
Reported Dec 31, 2014
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory Co.
Matched: Brand · Product · Product details — Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after…
FDA (openFDA device enforcement)
Reported Jul 23, 2014
ACL TOP (Base), automated coagulation laboratory instrument.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory Co.
Matched: Brand · Product · Product details — Potential for sample misidentification.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2013
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory Co.
Matched: Brand — HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2013
ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory Co.
Matched: Brand · Product details — Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2013
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory Co.
Matched: Brand · Reason for recall — Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
FDA (openFDA device enforcement)
Reported Sep 26, 2012
Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumentation Laboratory Co.
Matched: Brand · Product · Product details — Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
5 more products in this recall
FDA (openFDA device enforcement)
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