137 results
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28ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis (1) ACL TOP 550 CTS Model Number: 00000280045; (2) ACL TOP 750 CTS Model Number: 00000280055; (3) ACL TOP 350 CTS Model Number: 00000280065; (4) ACL TOP 750 Model Number: 00000280015; (5) ACL TOP 750 LAS Model Number: 00000280035 (6) ACL TOP 970 CL(only available ROW)Model Number: 00000280097
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code GKP·July 13, 2023
GEM Premier 5000; Part No. 00055445008.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000 PAK; Part No. 00055415004.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000; Part No. 00055445010 & 00055445011.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000 PAK; Part No. 00055360010.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000; Part No. 00055415008.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code QLU·August 25, 2021
HemosIL ReadiPlasTin, Part No. 0020301400
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code GJS·April 8, 2022
ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
GEM Premier 5000; Model No. 00055430010.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000; Part No. 00055430011.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code GFO·November 18, 2025
GEM Premier 5000; Part No. 00055430004.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
HemosIL LMW Heparin Controls; Part Number: 0020300200;
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2025
ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2023
GEM Premier 5000 PAK; Part No. 00055407510.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000; Part No: 00055415011.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000 PAK, Part No. 00055360004.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000; Part No. 00055430008.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026
GEM Premier 5000 PAK; Part No. 00055360011.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·January 20, 2026