Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall BD FACS Sample Prep Assistant III (BD SPA III) see related information
Date Initiated by Firm February 19, 2010
Date Posted November 03, 2010
Recall Status1 Terminated 3 on May 18, 2011
Recall Number Z-0316-2011
Recall Event ID 55748
Product Classification Counter, differential cell - Product Code GKZ
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.
Code Information Model/Catalog No. 647205. Manufacturing Lot/Serial # X0039; Sample Probe Catalog Numbers: 333494, 333485, 339118, 647768, and 647769/Lot Nos. 92035 and 92036
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		 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
FDA Determined
Cause 2		 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.
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.
-
-