SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
FDA device recall Z-1378-05 · posted 2005-08-17 · Terminated
Recall details
- Recalling firm
- Cepheid
- Reason for recall
- A problem in the software has the potential to be associated with the incorrect reporting of sample results.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NSR
- Distribution
- The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.
- Date initiated
- 2005-07-22
- Date posted
- 2005-08-17
- Date terminated
- 2006-04-14
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IDI-MRSA (K033415) | Infectio Diagnostic (I.D.I.), Inc. | 2004-03-18 |