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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall BD FACS Sample Prep Assistant II (SPA II) see related information
Date Initiated by Firm February 19, 2010
Date Posted June 30, 2010
Recall Status1 Terminated 3 on May 18, 2011
Recall Number Z-1940-2010
Recall Event ID 55654
510(K)Number K050191  
Product Classification blood sample preparer for flow cytometry analysis - Product Code GKZ
Product BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis
Code Information Sample Probe Catalog Numbers 337170, 333494, 333485, 339118, 647768, 647769, and lot numbers , 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
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
FDA Determined
Cause 2
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 in Commerce 349 units
Distribution Worldwide distribution: USA, Australia, Belgium, China (Hong Kong), Colombia, Jamaica, Korea, Mexico, Singapore and Uruguay.
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.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = BECTON DICKINSON & CO.
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