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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 January 25, 2016
Create Date February 23, 2016
Recall Status1 Terminated 3 on October 18, 2016
Recall Number Z-0851-2016
Recall Event ID 73155
Product Classification Reagents,specific,analyte - Product Code MVU
Product BD FMC7 FITC: Model 430918.
FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.

Product Usage:
Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.
Code Information Model number: 340918: Lot number: 5341918. Incorrect expiry date on label 03/31/2017. correct expiry should be 6/30/16.
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Melissa J. Quinn
408-954-6080
Manufacturer Reason
for Recall		 Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed on the vial label.
FDA Determined
Cause 2		 Under Investigation by firm
Action BD Biosciences sent an Urgent Medical Device Recall letters dated January 2016 via certified mail to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that the remaining stock of the product can be used until 6-30-16. however, if prefer they can discard all remaining stock of the affected lot and BD will replace. The letter request customers complete the Tracking/verification form and returned to BD Biosciences, per the instructions (mail, fax, or email). For questions contact your local BD representative or BD Customer Support at 877-232-8995 (prompt 3,3).
Quantity in Commerce 78
Distribution Worldwide Distribution - US Nationwide in the staates of TX, NY, GA, NJ, AL, MA, IL, PA, DC, FL, CA, MD, OK. and coutry of Taiwan.
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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