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Dade Actin FSL Activated PTT Reagent
Siemens Healthcare Diagnostics Products GmbH · Model 10873832 · UDI-DI 00630414640358
1
510(k) clearances
79
Adverse events (1 deaths)
4
Recalls
13
Facilities
Description
Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
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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