BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131
This recall has been terminated (originally issued April 10, 2008).
- Company
- Bd Biosciences
- Recall Initiated
- October 2, 2007
- Posted
- April 10, 2008
- Terminated
- December 13, 2010
- Recall Number
- Z-0526-2008
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.
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 / Code Info
Serial Numbers: T0246 to T0290 (except for T0274,T0275,T0277 and T0279)
Root Cause
Software change control
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.