Pefakit

Pentapharm AG · Model 502-02 · UDI-DI 07640175460013

GGW Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

Plasma based functional assay for the determination of resistance to activated protein C caused by the Factor V Leiden mutation (FV:Q506).

Recalls

Date	Firm	Reason
2013-03-11	Siemens 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
2011-12-19	Siemens 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,
2005-09-23	Dade Behring , Inc.	prolonged aPTT results
2005-04-13	Diagnostica 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.