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U.S. Department of Health and Human Services

Class 2 Device Recall BD FACS Sample Prep Assistant (SPA and SPA II)

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  Class 2 Device Recall BD FACS Sample Prep Assistant (SPA and SPA II) see related information
Date Initiated by Firm January 03, 2009
Create Date June 25, 2015
Recall Status1 Terminated 3 on March 10, 2011
Recall Number Z-1620-2011
Recall Event ID 51208
Product Classification Station, pipetting and diluting, for clinical use - Product Code JQW
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.
Code Information Lot Number: T0040
Recalling Firm/
Manufacturer		 BD Biosciences, Systems & Reagents
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact
408-954-6307
Manufacturer 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).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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