Recall Z-1651-2010
Cepheid · initiated February 19, 2010
Product
Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.
Codes / lots: Lot Numbers: 00401, 00502, 00701, 00702 (Expires 2010 07 11 for lot 00401 and 2010 09 05 for the rest).
Reason for recall
Firm has had an increasing number of customer complaints regarding higher than expected Indeterminate Test Results due to "Invalid" test reports from our system when they have been conducting their own internal validation studies using banked frozen repository specimens.
FDA-determined cause: Other
Action taken
Cepheid issued a notification to consignees regarding the affected product. Additional instructions were provided to consignees in order to avoid further "Indeterminate Results". For further information, contact Cepheid at 1-888-336-2743.
Details
- Recall number
- Z-1651-2010
- Initiated
- February 19, 2010
- Posted by FDA
- May 25, 2010
- Terminated
- March 23, 2011
- Quantity
- 1803 kits
- Distribution
- Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
- Recalling firm
- Cepheid, Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1652-2010 | Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA.…Firm has had an increasing number of customer complaints regarding higher than expected Indeterminate Test… | 02/19/2010Terminated |