Recall Z-0580-2008 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Medical Solutions Diagnostics
ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591
| Date | Jun 5, 2008 (initiated Jun 7, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 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 Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Swede |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053020 | TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Healthcare, LLC, Dec 30, 2005 |