Instrumentation Laboratory

Complete recall history across all FDA and CPSC categories — 38 total recalls

Instrumentation Laboratory appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (38)

FDA medical device enforcement actions by Instrumentation Laboratory

Date Product Reason Class
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055407504. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000; Part No. 00055445010 & 00055445011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055415004. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055360010. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000; Part No. 00055430011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000; Part No: 00055415011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000; Part No. 00055430004. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000; Part No. 00055415010. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000; Part No. 00055445004. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055360008. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055407510. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000; Part No. 00055445008. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055407508. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055360011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055407511. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000; Part No. 00055415008. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000; Part No. 00055430008. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000; Model No. 00055430010. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000; Part No. 00055415005. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Jan 20, 2026 GEM Premier 5000 PAK, Part No. 00055360004. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the G... Class II
Dec 11, 2025 The product is used for the evaluation of the intrinsic coagulation pathway, ... Potential for microbial contamination. Class II
Nov 18, 2025 HemosIL SynthAFax. Partial Thromboplastin Time Tests. Recalled lots were manufactured with double the amount of preservative concen... Class III
Feb 3, 2025 HemosIL LMW Heparin Controls; Part Number: 0020300200; Multiple complaints indicating lower than expected quality control (QC) resul... Class II
Dec 18, 2024 HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic Control indicating lower than expected quality control (QC) results and in so... Class II
Sep 29, 2023 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate... Internal testing identified that the GEM Premier PAKs (cartridges) may exhibi... Class II
Sep 29, 2023 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330... Internal testing identified that the GEM Premier PAKs (cartridges) may exhibi... Class II
Sep 29, 2023 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 000243... Internal testing identified that the GEM Premier PAKs (cartridges) may exhibi... Class II
Jul 13, 2023 ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use... Sample misidentification could occur under specific conditions and patient ... Class II
Feb 3, 2023 ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in... Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 002... Class II
Feb 3, 2023 ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis ... Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 002... Class II
Feb 3, 2023 ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostas... Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 002... Class II
Feb 3, 2023 ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the ... Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 002... Class II
Apr 8, 2022 HemosIL ReadiPlasTin, Part No. 0020301400 Variable and out of specification QC results with HemosIL ReadiPlasTin. IL w... Class II
Feb 22, 2022 ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP... Updated and revised user instructions issued 7/14/22. Potential carryover iss... Class II
Oct 13, 2021 HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic... The firm has received customer reports of performance issues with the affecte... Class II
Aug 25, 2021 HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... Labeled On-board instrument stability issue for current and future lots, redu... Class II
Aug 25, 2021 HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic ... Labeled On-board instrument stability issue for current and future lots, redu... Class II
Aug 25, 2021 HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... Labeled On-board instrument stability issue for current and future lots, redu... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.