Z-0316-2011

BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. The intended...

Name: Z-0316-2011 BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. The intended...
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: design

FDA source

BD Biosciences, Systems & Reagents began a recall of BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. The intended use for the BD FACS Sample Prep Assistant is to... on 2010-02-19. The reason FDA records is "Due to inaccurate sample dispense, use of product may result in getting incorrect results on samples prepared using the device. Having a piece of the lid partially or fully clogging the Probe during piercing a hole in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0316-2011
Status: Terminated
Initiated: 2010-02-19
Posted: 2010-11-03
Terminated: 2011-05-18
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis.
Product code: GKZ Counter, Differential Cell
Reason for recall: Due to inaccurate sample dispense, use of product may result in getting incorrect results on samples prepared using the device. Having a piece of the lid partially or fully clogging the Probe during piercing a hole in the lid of tube may cause inaccurate sample dispense, resulting in incorrect test results. The piece of the lid clogging the Probe can be in the processed sample tube. It has the
Root cause tag: design
FDA root cause: Device Design
Action: BD Biosciences sent an "Important Product Information" letter dated February 2010 and an "URGENT: Follow-Up to Letter Dated February 2010" letter dated July 2010 to customers identifying the affected device and actions to be taken: Customers were instructed to stop use of the SPA probes and to contact BD for replacement of the affected probes and assistance in the event of probe clogging. BD has arranged replacement of affected probes. BD's followup communication detailed the potenial hazards and reiterated remedial actions in the event of error messages from FACS flow cytometers. Customers with questions about the performance of theirr SPA instrument or the content of the letters may contact BD Customer Support at 1.877.232.8995, prompt 2.
Quantity in commerce: 349 units
Distribution: Worldwide distribution: USA including OH, NC, AL,TX, FL, CA, NY, and MN and the country of Belgium.
Product codes and lots: Model/Catalog No. 647205. Manufacturing Lot/Serial # X0039; Sample Probe Catalog Numbers: 333494, 333485, 339118, 647768, and 647769/Lot Nos. 92035 and 92036

Product code GKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)