9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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HemosIL SynthAFax. Partial Thromboplastin Time Tests.
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code GFO·November 18, 2025
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·September 29, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·September 29, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code CHL·September 29, 2023
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
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 Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro/8/9/10000) Part Number: 0020302600
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·August 25, 2021
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP Family, ACL TOP Family 50 Seriest and ACL Elite/Elite Pro) Part Number: 0020302601
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code N/A·August 25, 2021
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. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code GKP·February 22, 2022