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U.S. Department of Health and Human Services

Class 2 Device Recall BD Bioscience BD CD56 PECy 7

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  Class 2 Device Recall BD Bioscience BD CD56 PECy 7 see related information
Date Initiated by Firm July 17, 2015
Date Posted August 24, 2015
Recall Status1 Terminated 3 on March 11, 2016
Recall Number Z-2453-2015
Recall Event ID 71826
Product Classification Reagents,specific,analyte - Product Code MVU
Product BD CD56 PE Cy 7: NCAM16.2 ASR
Analyte Specific Reagent, Catalog number 335809

Hematology:
The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.
Code Information Catalog number 335809; Lot numbers 4300708, 4304864, 5013643; all with expiry dates of 31 OCT 2015
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information Contact Eric R. Claussen
408-954-6307
Manufacturer Reason
for Recall		 Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern.
FDA Determined
Cause 2		 Material/Component Contamination
Action BD Bioscience sent an Urgent Product Recall Letter dated July 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. If you have CD56 PE-Cy7 integrated into a Laboratory Developed Test (LDT) or panel, evaluate the impact of a false positive in the PE channel the interpretation of on the results. 2. Discard all remaining stock of CD56 PE-Cy7, Catalog Number 335809, lot number 4300708, 4304864, and/or 5013643, and request replacement product. BD will replace product at no cost. 3. 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) in the United States. For customers outside the US, contact your local BD Biosciences representative or distributor.
Quantity in Commerce 362 units
Distribution US Distribution and Internationally to 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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