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Terminated

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.

FDA Recall Z-1651-2010 · Posted 2010-05-25

Recalling FirmCepheid
Recall StatusTerminated
Product CodeOPU
Date Initiated2010-02-19
Date Terminated2011-03-23
Product Quantity1803 kits

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.

Firm Action

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

Distribution Pattern

Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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