SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
- Company
- Cepheid
- Recall Initiated
- July 22, 2005
- Posted
- August 17, 2005
- Terminated
- April 14, 2006
- Recall Number
- Z-1378-05
- Firm Location
- Sunnyvale, CA
Reason for Recall
A problem in the software has the potential to be associated with the incorrect reporting of sample results.
Distribution
The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.
Lot / Code Info
All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
Root Cause
Other
Action Taken
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.
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