| Class 3 Device Recall Cepheid Xpert Flu A Panel (GXFLUPANEL10) | |
Date Initiated by Firm | February 19, 2010 |
Date Posted | May 25, 2010 |
Recall Status1 |
Terminated 3 on March 23, 2011 |
Recall Number | Z-1651-2010 |
Recall Event ID |
55079 |
Product Classification |
Reagents, 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identific - Product Code OPU
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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. |
Code Information |
Lot Numbers: 00401, 00502, 00701, 00702 (Expires 2010 07 11 for lot 00401 and 2010 09 05 for the rest). |
Recalling Firm/ Manufacturer |
Cepheid 904 E Caribbean Dr Sunnyvale CA 94089-1189
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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 | 1803 kits |
Distribution | Worldwide Distribution -- United States, France, Belgium, Germany, Norway Austria, Denmark, Spain, Taiwan and Hong Kong. |
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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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