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U.S. Department of Health and Human Services

Class 2 Device Recall SmartCycler

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  Class 2 Device Recall SmartCycler see related information
Date Initiated by Firm July 22, 2005
Date Posted August 17, 2005
Recall Status1 Terminated 3 on April 14, 2006
Recall Number Z-1378-05
Recall Event ID 32756
510(K)Number K0022504  k033415  
Product Classification Prosthesis, Orthodontic - Product Code NSR
Product SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
Code Information All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
Recalling Firm/
Manufacturer		 Cepheid
904 E Caribbean Dr
Sunnyvale CA 94089-1189
For Additional Information Contact Russel K. Enns, Ph.D.
408-400-8230
Manufacturer Reason
for Recall		 A problem in the software has the potential to be associated with the incorrect reporting of sample results.
FDA Determined
Cause 2		 Other
Action On 7/22/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the corrective action.
Distribution The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = NSR and Original Applicant = INFECTIO DIAGNOSTIC (I.D.I.) INC.
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