Instrumentation Laboratory recalls
Every recall we track for Instrumentation Laboratory — 48 in all, from 2021–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Instrumentation Laboratory peaked in 2023 (8); 48 since 2017.
All FDA recall records for Instrumentation Laboratory since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 4 | 0 | 4 |
| 2022 | 0 | 0 | 2 | 0 | 2 |
| 2023 | 0 | 1 | 7 | 0 | 8 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 3 | 0 | 3 |
| 2026 (to date) | 0 | 2 | 27 | 1 | 30 |
What to do if you have a recalled Instrumentation Laboratory product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Instrumentation Laboratory recalls
15 shown- Use cautionMedical device
Instrumentation Laboratory recalls HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Instrumentation Laboratory recalls 1,414 HemoslL AcuStar HIT-lgG(PF-4) test kits with part number 0009802028 due to potential calibration errors. Affected units sold worldwide in 2026.
Instrumentation LaboratorySep 3, 2026 - Lower riskMedical device
Instrumentation Laboratory recalls GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010
Instrumentation Laboratory recalls specific GEM Premier 5000 PAK models due to lysing bag solution concentration issues that may delay detection of blood abnormalities.
Instrumentation LaboratoryMay 21, 2026 - Use cautionMedical device
Instrumentation Laboratory recalls GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number:
Instrumentation Laboratory recalls GEM Premier 5000 and 7000 blood analyzers with specific bar code reader wands that may assign patient results to the wrong ID. Affected units have model numbers starting with 00024019255 or 00000015279.
Instrumentation LaboratoryMay 8, 2026 - Lower riskMedical device
Instrumentation Laboratory recalls GEM Premier 5000 PAK, Part No. 00055360004.
GEM recalls specific PAK cartridges for the Premier 5000 that may cause repeated process errors during warm-up, requiring frequent cartridge replacements and potentially delaying test results.
GEMJan 20, 2026 - Lower riskMedical device
Instrumentation Laboratory recalls The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring
Instrumentation Laboratory recalls coagulation test kits with potential microbial contamination. Affected kits have specific part and lot numbers. Consumers should contact the manufacturer for details.
Instrumentation LaboratoryDec 11, 2025 - Lower riskMedical device
Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Instrumentation Laboratory recalls HemosIL SynthAFax partial thromboplastin time tests due to double preservative concentration in some lots. Affected units have specific lot numbers and expiration dates.
Instrumentation LaboratoryNov 18, 2025 - Lower riskMedical device
Instrumentation Laboratory recalls HemosIL LMW Heparin Controls; Part Number: 0020300200;
Instrumentation Laboratory recalls HemosIL LMW Heparin Controls (Part 0020300200) due to inconsistent quality control results that may cause patient testing delays. Affected units include specific lot numbers.
Instrumentation LaboratoryFeb 3, 2025 - Lower riskMedical device
Instrumentation Laboratory recalls HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Instrumentation Laboratory recalls HemosIL Heparin Calibrators (Part 0020300600) due to potential lower quality control results. Affected units include specific lot numbers listed in the recall notice.
Instrumentation LaboratoryDec 18, 2024 - Use cautionMedical device
Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007,
Instrumentation Laboratory recalls GEM Premier 3000 PAKs with specific part numbers that may show false high oxygen levels in low ranges, risking delayed treatment of hypoxemia. Affected units include certain pH, pCO2, pO2, Hct, Na+, K+, Ca++ cartridges.
Instrumentation LaboratorySep 29, 2023 - Lower riskMedical device
Instrumentation Laboratory recalls ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for
Instrumentation Laboratory recalls ACL TOP Family 50 Series models for potential sample misidentification in hemostasis labs, risking incorrect patient results. Affected units include specific models and software versions.
Instrumentation LaboratoryJul 13, 2023 - Lower riskMedical device
Instrumentation Laboratory recalls ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation
Instrumentation Laboratory recalls ACL Elite refurbished analyzers that no longer support HemosIL Liquid Anti-Xa tests. This affects hemostasis lab equipment used for coagulation testing.
Instrumentation LaboratoryFeb 3, 2023 - Lower riskMedical device
Instrumentation Laboratory recalls HemosIL ReadiPlasTin, Part No. 0020301400
Instrumentation Laboratory recalls HemosIL ReadiPlasTin (Part No. 0020301400) due to variable QC results. All in-date lots affected; customers will switch to HemosIL RecombiPlasTin 2G.
Instrumentation LaboratoryApr 8, 2022 - Lower riskMedical device
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
Instrumentation Laboratory recalls ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL analyzers due to potential elevated results for heparin, apixaban, or rivaroxaban when used with specific reagents. Affected units have serial numbers listed in the recall notice.
Instrumentation LaboratoryFeb 22, 2022 - Lower riskMedical device
Instrumentation Laboratory recalls HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Instrumentation Laboratory recalls HemosIL ReadiPlasTin (20mL) lot N0705526 and N0806224 due to potential inaccurate test results. Affected users should check their product labels.
Instrumentation LaboratoryOct 13, 2021 - Lower riskMedical device
Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH)
Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- for reduced on-board instrument stability from 7 to 5 days. Affected units may cause inaccurate heparin measurements.
Instrumentation LaboratoryAug 25, 2021
Instrumentation Laboratory recall questions
How many recalls has Instrumentation Laboratory had?
48 recalls from Instrumentation Laboratory are on record with U.S. safety agencies, from 2021–2026.
What is the most recent Instrumentation Laboratory recall?
Instrumentation Laboratory recalls HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only), dated Sep 3, 2026. Every Instrumentation Laboratory recall is listed on this page, newest first.
What should I do if I have a recalled Instrumentation Laboratory product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Instrumentation Laboratory recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.