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HEMOCLOT Quanti. V-L

HYPHEN BIOMED · Model CK065K · UDI-DI 03663537017964

GGW
1
510(k) clearances
79
Adverse events (1 deaths)
4
Recalls
13
Facilities

Recalls

DateFirmReason
2013-03-11Siemens Healthcare Diagnostics, Inc.Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control
2011-12-19Siemens Healthcare Diagnostics, Inc.The listed lots of Dade(R) Actin(R) FSL Reagent show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control,
2005-09-23Dade Behring , Inc.prolonged aPTT results
2005-04-13Diagnostica Stago, Inc.Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.