Z-1378-05

SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler

Name: Z-1378-05 SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
Creator: Cepheid
Published: 2005-07-22
License: https://open.fda.gov/license/

Cepheid / initiated 2005-07-22 / Terminated / root cause: software

FDA source

Cepheid began a recall of SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler on 2005-07-22. The reason FDA records is "A problem in the software has the potential to be associated with the incorrect reporting of sample results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1378-05
Status: Terminated
Initiated: 2005-07-22
Posted: 2005-08-17
Terminated: 2006-04-14
Recalling firm: Cepheid
Product: SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
Product code: NSR Prosthesis, Orthodontic
Reason for recall: A problem in the software has the potential to be associated with the incorrect reporting of sample results.
Root cause tag: software
FDA root cause: Other
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.
Distribution: The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.
Product codes and lots: All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a

Product code NSR

K033415Class IIIdi-MrsaInfectio Diagnostic (I.D.I.), Inc. / cleared 2004-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)