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U.S. Department of Health and Human Services

Class 2 Device Recall BD FACS 7color Setup Beads

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 Class 2 Device Recall BD FACS 7color Setup Beadssee related information
Date Initiated by FirmJune 29, 2012
Date PostedSeptember 17, 2012
Recall Status1 Terminated 3 on March 25, 2013
Recall NumberZ-2397-2012
Recall Event ID 62494
510(K)NumberK040026 
Product Classification Counter, differential cell - Product Code GKZ
ProductBD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
Code Information Catalog number: 335775; Lot number 33412.
FEI Number 2916837
Recalling Firm/
Manufacturer		 BD Biosciences, Systems & Reagents
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information ContactEric R Claussen
408-954-6348
Manufacturer Reason
for Recall		Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.
FDA Determined
Cause 2		Employee error
ActionBD Biosciences sent a Important Product Recall Information letter beginning July 3, 2012, to all affected consignees via Fed Express. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed that the CD enclosed in their recent purchase of BD FACS 7-Color Setup Beads, lot number 33412, contain CD version 2.0 instead of the newer version 3.0. The letter goes on to explain the the potential risk and include a table of listed range values to determine if a potential false pass or false fail for the listed detectors has occurred. Customers are asked to check the CD with the kit to ensure that it is version 3.0 (the kit lot number ID is on the CD label). If it is not the correct version, discard version 2.0 and do not use it with this bead kit. Call BAD customers service for a replacement. If the 2.0 kit was already uses, letters request that clinicians inspect the FITC and APC-CY7 stains in the plots of the laboratory reports for the clinical applications in BD FACSCanto clinical software for compromised resolution between negative and dim populations. The verification form/effectiveness check should be completed and returned as requested. Questions or concerns may be directed to BD Customer Support at 1-855-236-2772.
Quantity in Commerce96 kits
DistributionWorldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GKZ
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