FDA Medical Device Recalls (openFDA)
Cepheid: SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
- Recall number
- Z-1378-05
- Recalling firm
- Cepheid
- Product
- SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
- Status
- Terminated
- Initiated
- 2005-07-22
- Posted
- 2005-08-17
- Terminated
- 2006-04-14
- Reason
- A problem in the software has the potential to be associated with the incorrect reporting of sample results.
- 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.
- Quantity
- not on file
- Distribution
- The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors.
- Lot, serial or model codes
- All units with software code version #s: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
- 510(k) numbers
- ["K033415"]
- PMA numbers
- not on file
- Product code
- NSR
- Firm FEI
- 3004530258
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28