BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic

FDA device recall Z-2397-2012 · posted 2012-09-17 · Terminated

Recall details

Recalling firm

BD Biosciences, Systems & Reagents

Reason for recall

Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.

Action taken

BD 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.

Root cause

Employee error

Status

Terminated

Product code

GKZ

Quantity affected

96 kits

Distribution

Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.

Date initiated

2012-06-29

Date posted

2012-09-17

Date terminated

2013-03-25

Location

San Jose, CA

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