ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog #
FDA device recall Z-0580-2008 · posted 2008-06-05 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions Diagnostics
- Reason for recall
- Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other Troponin assays.
- Action taken
- Two Support Bulletins (078N0361-01 & 078N0361-02) were sent by e-mail to all affected Siemens Diagnostics Branches to inform them of this issue. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. Two Customer Bulletins (078D0647-01 & 078D0651-01) were sent by e-mail to the Siemens Diagnostics Branches for communication with the affected customers. The first one was sent on 6/07/07 and the second one was sent on 7/05/07. These bulletins state that if a false positive is suspected, the sample should be diluted and retested.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- Domestic: 31,497 kits; Foreign: 27,321 kits
- Distribution
- Worldwide Distribution - USA, Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Morocco, Netherlands, New Zeala
- Date initiated
- 2007-06-07
- Date posted
- 2008-06-05
- Date terminated
- 2012-08-28
- Location
- Tarrytown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM (K053020) | Bayer Healthcare, LLC | 2005-12-30 |