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U.S. Department of Health and Human Services

Class 3 Device Recall BD CD3 (SK7) FITC

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  Class 3 Device Recall BD CD3 (SK7) FITC see related information
Date Initiated by Firm September 30, 2015
Create Date November 04, 2015
Recall Status1 Terminated 3 on October 18, 2016
Recall Number Z-0171-2016
Recall Event ID 72321
510(K)Number K842218  
Product Classification Assay, t lymphocyte surface marker - Product Code LIZ
Product BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542

Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
Code Information Catalog Number: 349201; Lot Number 5148598 (expires 10-31-2016) Catalog Number: 340542; Lot Number 5113983 (expires 02-28-2017)
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		 Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
FDA Determined
Cause 2		 Under Investigation by firm
Action BD sent an "URGENT PRODUCT RECALL" letter dated September 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer Actions: 1. Discard all remaining stock of CD3 (SK7) FITC, catalog number 349201, lot number 5148598, and/or catalog number 340542, lot number 5113983, and request replacement product. BD will replace product at no cost. 2.As a requirement of our Regulatory Tracking Process, we request that you complete the enclosed Tracking Verification form, even if you no longer have the affected reagents listed in your inventory. Please return the Tracking Verification form to BD Biosciences, per the instructions (mail, fax, or email). We apologize for any inconvenience that this may have caused and are working toward a long-term solution to this issue. If you require further assistance, please contact BD Customer Support at 877.232.8995 (prompt 3, 3) in the United States. For customers outside the US, contact your local BD Biosciences representative or distributor.
Quantity in Commerce 120 units
Distribution US (nationwide) Distribution to the states of : TX, GA, IN, TN, CA, KY, WA, IL, MO, NY, CT, MN, NV, KS, WI, NH, FL, PA, OH, OR, SC. OK, NC and LA., and Internationally to Mexico.
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.
510(K) Database 510(K)s with Product Code = LIZ and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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