BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jo
FDA device recall Z-0526-2008 · posted 2008-04-10 · Terminated
Recall details
- Recalling firm
- BD Biosciences
- Reason for recall
- Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.
- Action taken
- On 10/1/07, all consignees were notified via Important Product Information letter and also an on-site visit by the firm's sales representative. The letter informed users of the affected product and provided instructions on the recall. For additional concerns or questions contact BD Customer Support Center at 1-877-232-8995.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- GKI
- Distribution
- Worldwide Distribution --- USA including states of: NJ, IL, TX, PA, NY, MN, and AZ, and countries of Australia, Belgium, Hong Kong, Trinidad and Tobago. Australia, Belgium, Hong Kong, Trinidad and Tob
- Date initiated
- 2007-10-02
- Date posted
- 2008-04-10
- Date terminated
- 2010-12-13
- 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 |