Instrumentation Laboratory recalls
14 official recalls and safety alerts involving Instrumentation Laboratory since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Instrumentation Laboratory or the relevant agency.
- 2026-08-12
USInstrumentation Laboratory recalls GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011…
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management…
FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL,…Official notice →- 2026-08-05
- US
Instrumentation Laboratory recalls Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
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.
- 2026-03-18
- US
Instrumentation Laboratory recalls GEM Premier 5000 PAK, Part No. 00055360004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including…
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2026-01-21
- US
Instrumentation Laboratory recalls The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin…
Potential for microbial contamination.
FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS,…Official notice → - 2025-12-24
- US
Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Recalled lots were manufactured with double the amount of preservative concentration.
FDA · DeviceInstrumentation LaboratoryDomestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL,…Official notice → - 2025-08-20
- US
Instrumentation Laboratory recalls HemosIL 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 the package insert acceptance range when testing is performed with HemosIL…
FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide and the countries of Algeria, Andorra, Argentina,…Official notice → - 2025-02-05
- US
Instrumentation Laboratory recalls HemosIL 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 insert acceptance range.
FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide and the countries of Andorra, Algeria, Armenia,…Official notice → - 2023-11-29
- US
Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
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 than 60 mmHg) that are outside of labeled…
- 2023-09-20
- US
Instrumentation Laboratory recalls ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or…
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Canada, Finland,…Official notice → - 2023-04-05
- US
Instrumentation Laboratory recalls ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or…
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Canada, Albania,…Official notice → - 2022-05-18
- US
Instrumentation Laboratory recalls HemosIL ReadiPlasTin, Part No. 0020301400
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 (PT) reagent, specifically HemosIL RecombiPlasTin…
FDA · DeviceInstrumentation LaboratoryUS Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS,…Official notice → - 2022-05-04
- US
Instrumentation Laboratory recalls 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 00000280060R…
Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in…
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2021-12-01
- US
Instrumentation Laboratory recalls HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or…
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - 2021-10-27
- US
Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low…
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
FDA · DeviceInstrumentation LaboratoryUS Nationwide Foreign: Canada Armenia Austria Australia Belgium Brunei Brazil…Official notice →