Drug & Device Safety Atlas

FDA recall record · openFDA

Instrumentation Laboratory

32 FDA recalls on record (2023–2026) — 32 device. 32 still ongoing.

0

Class I (most serious)

31

Class II

1

Class III

32

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased 20

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instr 4

Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of 3

Recalled lots were manufactured with double the amount of preservative concentration. 1

Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly 1

Recalls

GEM Premier 5000 PAK, Part No. 00055360004. Class II 2026-01-20 GEM Premier 5000; Part No. 00055415005. Class II 2026-01-20 GEM Premier 5000; Model No. 00055430010. Class II 2026-01-20 GEM Premier 5000; Part No. 00055430008. Class II 2026-01-20 GEM Premier 5000; Part No. 00055415008. Class II 2026-01-20 GEM Premier 5000 PAK; Part No. 00055407511. Class II 2026-01-20 GEM Premier 5000 PAK; Part No. 00055360011. Class II 2026-01-20 GEM Premier 5000 PAK; Part No. 00055407508. Class II 2026-01-20 GEM Premier 5000; Part No. 00055445008. Class II 2026-01-20 GEM Premier 5000 PAK; Part No. 00055407510. Class II 2026-01-20 GEM Premier 5000 PAK; Part No. 00055360008. Class II 2026-01-20 GEM Premier 5000; Part No. 00055445004. Class II 2026-01-20 GEM Premier 5000; Part No. 00055415010. Class II 2026-01-20 GEM Premier 5000; Part No. 00055430004. Class II 2026-01-20 GEM Premier 5000; Part No: 00055415011. Class II 2026-01-20 GEM Premier 5000; Part No. 00055430011. Class II 2026-01-20 GEM Premier 5000 PAK; Part No. 00055360010. Class II 2026-01-20 GEM Premier 5000 PAK; Part No. 00055415004. Class II 2026-01-20 GEM Premier 5000; Part No. 00055445010 & 00055445011. Class II 2026-01-20 GEM Premier 5000 PAK; Part No. 00055407504. Class II 2026-01-20 HemosIL LMW Heparin Controls; Part Number: 0020300200; Class II 2025-02-03 The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring o Class II 2025-12-11 HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic Class II 2024-12-18 ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/ Class II 2023-02-03 ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibri Class II 2023-02-03 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 0002434500 Class II 2023-09-29 ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulati Class II 2023-07-13 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004 Class II 2023-09-29 ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinol Class II 2023-02-03 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00 Class II 2023-09-29 ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation Class II 2023-02-03 HemosIL SynthAFax. Partial Thromboplastin Time Tests. Class III 2025-11-18

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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