Instrumentation Laboratory
12 recalls on record · Latest: Dec 24, 2025
FDA Devices Low Dec 24, 2025
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
FDA Devices Moderate Aug 20, 2025
HemosIL LMW Heparin Controls; Part Number: 0020300200;
FDA Devices Moderate Feb 5, 2025
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
FDA Devices Moderate Nov 29, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
FDA Devices Moderate Nov 29, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
FDA Devices Moderate Sep 20, 2023
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testin…
FDA Devices Moderate Apr 5, 2023
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Par…
FDA Devices Moderate Apr 5, 2023
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number…
FDA Devices Moderate Apr 5, 2023
ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0…
FDA Devices Moderate May 18, 2022
HemosIL ReadiPlasTin, Part No. 0020301400
FDA Devices Moderate May 4, 2022
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 (Refurbished) 3…
FDA Devices Moderate Dec 1, 2021