Recall Z-0580-2008
Siemens Medical Solutions Diagnostics · initiated June 7, 2007
Product
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
Codes / lots: All lots. 500 tests: Part/Catalog #02790309, and 100 tests: Part/Catalog # 02789602.
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.
FDA-determined cause: Material/Component Contamination
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.
Details
- Recall number
- Z-0580-2008
- Initiated
- June 7, 2007
- Posted by FDA
- June 5, 2008
- Terminated
- August 28, 2012
- Product code
- MMI – Immunoassay Method, Troponin Subunit
- 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, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela
- Recalling firm
- Siemens Medical Solutions Diagnostics, Tarrytown, NY