Z-1620-2011

BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, Model Number: 334080, Product is manufactured and...

Name: Z-1620-2011 BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, Model Number: 334080, Product is manufactured and...
Creator: BD Biosciences, Systems & Reagents
Published: 2009-01-03
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2009-01-03 / Terminated / root cause: manufacturing process

FDA source

BD Biosciences, Systems & Reagents began a recall of BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, Model Number: 334080, Product is manufactured and distributed by BD Biosciences, San Jose, CA The... on 2009-01-03. The reason FDA records is "To prevent a needle stick while replacing the probe, the firm has initiated a Field Correction, and issued an improved Users Guide procedure (User Bulletin, Part Number 645050)". 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-1620-2011
Status: Terminated
Initiated: 2009-01-03
Posted: 2015-06-25
Terminated: 2011-03-10
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, Model Number: 334080, Product is manufactured and distributed by BD Biosciences, San Jose, CA The intended use for the BD FACS Sample Prep Assistant (SPA and SPA II) is to prepare human whole blood for flow cytometry.
Product code: JQW Station, Pipetting And Diluting, For Clinical Use
Reason for recall: To prevent a needle stick while replacing the probe, the firm has initiated a Field Correction, and issued an improved Users Guide procedure (User Bulletin, Part Number 645050).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, BD Biosciences, sent an information letter dated December 2008 with an enclosed New Probe Replacement Service/User Bulletin, to the customers. The letter described the product, problem and action to be taken. The customers were instructed to review the attached User Bulletin (Part Number 645050); ensure that their laboratory follows the updated procedure for removing and replacing probe; place the User Bulletin in their BD FACS SPA or SPA II User's Guide; always follow the instructions in User Bulletin to properly remove and replace probe, and complete and return the Effectivity Form via fax to 408-577-1409. Should you have any comments or questions, please contact BD Biosciences at 1-877-232-8995 in the US. Outside the US, contact your regional BD office or field service engineer for assistance.
Quantity in commerce: 70
Distribution: Worldwide distribution: USA and countries including: Hong Kong, Australia, Belgium, Canada, El Salvador, Hong Kong, Japan, and Mexico.
Product codes and lots: Lot Number: T0040

Product code JQW

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)