BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis
FDA device recall Z-1940-2010 · posted 2010-06-30 · Terminated
Recall details
- Recalling firm
- BD Biosciences, Systems & Reagents
- Reason for recall
- Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe
- Action taken
- The firm filed an MDR and implemented a field action consisting of a February 2010 notification letter and product replacement of affected probes. A CAPA for the probe design has been implemented. Effectivity is being tracked via mail and follow up phone call.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 349 units
- Distribution
- Worldwide distribution: USA, Australia, Belgium, China (Hong Kong), Colombia, Jamaica, Korea, Mexico, Singapore and Uruguay.
- Date initiated
- 2010-02-19
- Date posted
- 2010-06-30
- Date terminated
- 2011-05-18
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE (K050191) | Becton, Dickinson & CO | 2005-02-22 |