Cepheid SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
Brand
Cepheid
Lot Codes / Batch Numbers
All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
Products Sold
All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
Cepheid is recalling SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler due to A problem in the software has the potential to be associated with the incorrect reporting of sample results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A problem in the software has the potential to be associated with the incorrect reporting of sample results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026