Z-1940-2010

BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis

Name: Z-1940-2010 BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis
Creator: BD Biosciences, Systems & Reagents
Published: 2010-02-19
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2010-02-19 / Terminated / root cause: manufacturing process

FDA source

BD Biosciences, Systems & Reagents began a recall of BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis on 2010-02-19. The reason FDA records is "Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1940-2010
Status: Terminated
Initiated: 2010-02-19
Posted: 2010-06-30
Terminated: 2011-05-18
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis
Product code: GKZ Counter, Differential Cell
Reason for recall: Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm filed an MDR and implemented a field action consisting of a February 2010 notification letter and product replacement of affected probes. A CAPA for the probe design has been implemented. Effectivity is being tracked via mail and follow up phone call.
Quantity in commerce: 349 units
Distribution: Worldwide distribution: USA, Australia, Belgium, China (Hong Kong), Colombia, Jamaica, Korea, Mexico, Singapore and Uruguay.
Product codes and lots: Sample Probe Catalog Numbers 337170, 333494, 333485, 339118, 647768, 647769, and lot numbers , 92035 and 92036.

Product code GKZ

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)