Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as an automated multiplex r
FDA device recall Z-1651-2010 · posted 2010-05-25 · Terminated
Recall details
- Recalling firm
- Cepheid
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- OPU
- Quantity affected
- 1803 kits
- Distribution
- Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
- Date initiated
- 2010-02-19
- Date posted
- 2010-05-25
- Date terminated
- 2011-03-23
- Location
- Sunnyvale, CA
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