| 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 | 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. |
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FDA Determined
Cause 2 | Other |
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| 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. |
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| Distribution | The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors. |
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| 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
|
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