Recall Z-0526-2008 ยท GKI
BD Biosciences
BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131
| Date | Apr 10, 2008 (initiated Oct 2, 2007) |
| Status | Terminated |
| Reason | Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance. |
| Root cause | Software change control |
| Action | 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. |
| 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 Tobago. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050191 | MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE Becton, Dickinson & CO, Feb 22, 2005 |