FDA Medical Device Recalls (openFDA)
BD Biosciences, Systems & Reagents: BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis
- Recall number
- Z-1940-2010
- Recalling firm
- BD Biosciences, Systems & Reagents
- Product
- BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis
- Status
- Terminated
- Initiated
- 2010-02-19
- Posted
- 2010-06-30
- Terminated
- 2011-05-18
- Reason
- 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
- 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
- 349 units
- Distribution
- Worldwide distribution: USA, Australia, Belgium, China (Hong Kong), Colombia, Jamaica, Korea, Mexico, Singapore and Uruguay.
- Lot, serial or model codes
- Sample Probe Catalog Numbers 337170, 333494, 333485, 339118, 647768, 647769, and lot numbers , 92035 and 92036.
- 510(k) numbers
- ["K050191"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2916837
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28