FDA Medical Device Recalls (openFDA)
BD Biosciences: BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131
- Recall number
- Z-0526-2008
- Recalling firm
- BD Biosciences
- Product
- BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131
- Status
- Terminated
- Initiated
- 2007-10-02
- Posted
- 2008-04-10
- Terminated
- 2010-12-13
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- Serial Numbers: T0246 to T0290 (except for T0274,T0275,T0277 and T0279)
- 510(k) numbers
- ["K050191"]
- PMA numbers
- not on file
- Product code
- GKI
- Firm FEI
- 2916837
- Firm city
- San Jose
- 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