Brand

Instrumentation Laboratory Recalls

25 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Instrumentation Laboratory.

25Total Recalls
0Critical
68,937Units Affected
Jan 20, 2026Most Recent
All Recalls

Every Instrumentation Laboratory Recall

Sorted by most recent. Click any recall for full details.

25 recalls
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK, Part No. 00055360004.
Medical Devices·51 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415005.
Medical Devices·8 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Model No. 00055430010.
Medical Devices·1,607 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430008.
Medical Devices·74 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415008.
Medical Devices·195 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407511.
Medical Devices·27 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360011.
Medical Devices·10 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407508.
Medical Devices·180 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445008.
Medical Devices·70 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407510.
Medical Devices·1,126 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360008.
Medical Devices·30 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445004.
Medical Devices·130 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415010.
Medical Devices·1,629 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430004.
Medical Devices·253 affected·Jan 20, 2026
High RiskFDA
Instrumentation Laboratory
GEM Premier 5000; Part No: 00055415011.
Medical Devices·7 affected·Jan 20, 2026
RecallFDA
Instrumentation Laboratory
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Medical Devices·4,506 affected·Nov 18, 2025
High RiskFDA
Instrumentation Laboratory
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Medical Devices·41,824 affected·Feb 3, 2025
High RiskFDA
Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Medical Devices·2,448 affected·Sep 29, 2023
High RiskFDA
Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Medical Devices·2,448 affected·Sep 29, 2023
High RiskFDA
Instrumentation Laboratory
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrino...
Diagnostic Devices·2,068 affected·Jul 13, 2023
High RiskFDA
Instrumentation Laboratory
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis t...
Medical Devices·1 affected·Feb 3, 2023
High RiskFDA
Instrumentation Laboratory
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. ...
Medical Devices·129 affected·Feb 3, 2023
High RiskFDA
Instrumentation Laboratory
HemosIL ReadiPlasTin, Part No. 0020301400
Medical Devices·1,563 affected·Apr 8, 2022
High RiskFDA
Instrumentation Laboratory
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 (Ref...
Medical Devices·2,725 affected·Feb 22, 2022
High RiskFDA
Instrumentation Laboratory
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Diagnostic Devices·5,828 affected·Oct 13, 2021