BD Viper LT software, version 3.00H
FDA device recall Z-1866-2017 · posted 2017-04-04 · Terminated
Recall details
- Recalling firm
- Bd Diagnostic
- Reason for recall
- BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results.
- Action taken
- Recall action was initiated on December 14, 2015 when software version 3.00H was removed from the two customer instruments. The 2 affected US customers were contacted via email and were also mailed a letter via UPS overnight express.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OOI
- Quantity affected
- 2
- Distribution
- 2 US customers, 0 Ex-US regions, and 0 distributors 0.
- Date initiated
- 2015-12-14
- Date posted
- 2017-04-04
- Date terminated
- 2017-04-19
- Location
- Sparks, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD VIPER LT SYSTEM (K140447) | Becton, Dickinson and Company | 2014-05-20 |