BD Biosciences, Systems & Reagents 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
BD Biosciences, Systems & Reagents
Lot Codes / Batch Numbers
Lot Number: T0040
Products Sold
Lot Number: T0040
BD Biosciences, Systems & Reagents is recalling BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, Model Number: 334080, Product is manufac due to To prevent a needle stick while replacing the probe, the firm has initiated a Field Correction, and issued an improved Users Guide procedure (User Bul. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026