SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
FDA Recall Z-1378-05 · Posted 2005-08-17
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Recalling FirmCepheid
Recall StatusTerminated
Product CodeNSR
Date Initiated2005-07-22
Date Terminated2006-04-14
Reason for Recall
A problem in the software has the potential to be associated with the incorrect reporting of sample results.
Firm 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.
Root Cause
Other
Distribution Pattern
The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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