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.
Recall
- Recall Number
- Z-1651-2010
- Event Number
- 55079
- Firm
- Cepheid
- FEI Number
- 3004530258
- Product Code
- OPU
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 19, 2010
- Posted
- May 25, 2010
- Terminated
- March 23, 2011
- Address
- 904 E Caribbean Dr, Sunnyvale, CA, 94089-1189
Description
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.
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.
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.
Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
1803 kits