FDA Device Intelligence
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Instrument, Coagulation, Automated

FDA product code GKP · Class 2 · Hematology

41
Registered devices
661
Adverse events
31
Recalls
49
510(k) clearances

Devices with this code

BCS® System Cuvette Rotors — Siemens Healthcare Diagnostics Products GmbHACL TOP 700 CTS — INSTRUMENTATION LABORATORY COMPANYACL TOP 750 LAS — INSTRUMENTATION LABORATORY COMPANYACL TOP 770 LAS — INSTRUMENTATION LABORATORY COMPANYACL TOP 570 — INSTRUMENTATION LABORATORY COMPANYHemosIL Factor Diluent — INSTRUMENTATION LABORATORY COMPANYACL TOP 550 CTS — INSTRUMENTATION LABORATORY COMPANYAutomated Blood Coagulation Analyzer CA-600 series CA-660 — SYSMEX CORPORATIONACL TOP 750 — INSTRUMENTATION LABORATORY COMPANYACL TOP 770s — INSTRUMENTATION LABORATORY COMPANYHemosIL Sample Diluent — INSTRUMENTATION LABORATORY COMPANYCA CAL S — SYSMEX CORPORATIONACL AcuStar cuvettes (1400 pcs) — INSTRUMENTATION LABORATORY COMPANYCA CAL S — SYSMEX CORPORATIONCuvettes (2400 cuvettes) — INSTRUMENTATION LABORATORY COMPANYCascade M-4 (110V/220V) — HELENA LABORATORIES CORPORATIONHemosIL Reference Emulsion — INSTRUMENTATION LABORATORY COMPANYAutomated Blood Coagulation Analyzer CA-600 series CA-660 — SYSMEX CORPORATIONACL TOP 500 CTS — INSTRUMENTATION LABORATORY COMPANYACL TOP 350 CTS — INSTRUMENTATION LABORATORY COMPANYACL TOP 500 CTS — INSTRUMENTATION LABORATORY COMPANYACL TOP 300 CTS — INSTRUMENTATION LABORATORY COMPANYACL TOP 700 CTS — INSTRUMENTATION LABORATORY COMPANYBC Validation Kit — Siemens Healthcare Diagnostics Products GmbH

Recent recalls

DateFirmReason
2023-07-13Instrumentation LaboratorySample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
2022-02-22Instrumentation LaboratoryUpdated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or r
2014-06-03Instrumentation Laboratory Co.Potential for sample misidentification.
2014-06-03Instrumentation Laboratory Co.Potential for sample misidentification.
2014-06-03Instrumentation Laboratory Co.Potential for sample misidentification.
2014-06-03Instrumentation Laboratory Co.Potential for sample misidentification.
2014-06-03Instrumentation Laboratory Co.Potential for sample misidentification.
2014-06-03Instrumentation Laboratory Co.Potential for sample misidentification.
2014-06-03Instrumentation Laboratory Co.Potential for sample misidentification.
2013-07-19Instrumentation Laboratory Co.Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

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