Home › Siemens Healthcare Diagnostics Products GmbH › Dade Actin FS Activated PTT Reagent
Dade Actin FS Activated PTT Reagent
Siemens Healthcare Diagnostics Products GmbH · Model 10873828 · UDI-DI 00630414640327
1
510(k) clearances
79
Adverse events (1 deaths)
4
Recalls
13
Facilities
Description
Liquid purified soy 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.