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U.S. Department of Health and Human Services

Class 2 Device Recall BD Biosciences Systems and Reagents

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 Class 2 Device Recall BD Biosciences Systems and Reagentssee related information
Date Initiated by FirmMarch 23, 2015
Date PostedApril 02, 2015
Recall Status1 Terminated 3 on February 26, 2016
Recall NumberZ-1375-2015
Recall Event ID 70811
Product Classification Reagents,specific,analyte - Product Code MVU
ProductCD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
Code Information Lot 5008762, Exp 11/30/16.
Recalling Firm/
Manufacturer		 BD Biosciences, Systems & Reagents
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information ContactMelissa J. Quinn
408-954-6080
Manufacturer Reason
for Recall		One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern.
FDA Determined
Cause 2		Under Investigation by firm
ActionRecall letters were sent to affected sites on March 23, 2015 by certified mail. All product in house was placed on ship hold and remaining inventory is in process of being scrapped.
Quantity in Commerce9
DistributionUS Distribution in states of: MO, GA, AZ, NE, TX, VA
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.
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