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ACTICLOT Protein C Resistance Kit
Biomedica ADI Inc. · Model 840 · UDI-DI 00850201006192
GGW
Prescription
10
510(k) clearances
79
Adverse events (1 deaths)
4
Recalls
13
Facilities
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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Get your free API keyRead the docsData 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.