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U.S. Department of Health and Human Services

Class 3 Device Recall BD FMC7 FITC

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  Class 3 Device Recall BD FMC7 FITC see related information
Date Initiated by Firm December 14, 2015
Date Posted January 11, 2016
Recall Status1 Terminated 3 on October 31, 2016
Recall Number Z-0628-2016
Recall Event ID 72885
Product Classification Reagents,specific,analyte - Product Code MVU
Product FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
Code Information Lot No. 4162520, 4206855, 4267919, 4276818, 4309977, 5009530, 5036624, 5085573, 5182818
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact
408-954-6307
Manufacturer Reason
for Recall		 Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%.
FDA Determined
Cause 2		 Under Investigation by firm
Action BD Biosciences sent an Urgent Product Recall letter dated December 2015, to all affected customers to inform them that Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to return the Tracking/Verification form to BD Biosciences. Customers are instructed to contact BD Customer Support at (877) 232-8995 (prompt 3, 3) in the US. Customers outside of the US are instructed to contact their local BD Biosciences or distributor.
Quantity in Commerce 1,388 units
Distribution Nationwide Distribution
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.
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