Z-0526-2008

BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD...

Name: Z-0526-2008 BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD...
Creator: BD Biosciences
Published: 2007-10-02
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2007-10-02 / Terminated / root cause: software

FDA source

BD Biosciences began a recall of BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131 on 2007-10-02. The reason FDA records is "Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0526-2008
Status: Terminated
Initiated: 2007-10-02
Posted: 2008-04-10
Terminated: 2010-12-13
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131
Product code: GKI
Reason for recall: Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.
Root cause tag: software
FDA 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.
Product codes and lots: Serial Numbers: T0246 to T0290 (except for T0274,T0275,T0277 and T0279)

Product code GKI

K050191Class IModification to Bd Facscanto System with Bd Facscanto Clinical SoftwareBecton, Dickinson & CO / cleared 2005-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)