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U.S. Department of Health and Human Services

Class 3 Device Recall Cepheid Xpert Flu A Panel (GXFLUPANELCE10)

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  Class 3 Device Recall Cepheid Xpert Flu A Panel (GXFLUPANELCE10) see related information
Date Initiated by Firm February 19, 2010
Date Posted May 25, 2010
Recall Status1 Terminated 3 on March 23, 2011
Recall Number Z-1652-2010
Recall Event ID 55079
Product Classification Reagents, 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identific - Product Code OPU
Product Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-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.
Code Information Lot Number: 00501 (Expires 2010 08 08)  
Recalling Firm/
Manufacturer		 Cepheid
904 E Caribbean Dr
Sunnyvale CA 94089-1189
For Additional Information Contact
408-541-4191
Manufacturer 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 2		 Other
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.
Quantity in Commerce 944 kits
Distribution Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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