Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BD Bioscience BD CD56 PECy 7

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall BD Bioscience BD CD56 PECy 7see related information
Date Initiated by FirmJuly 17, 2015
Date PostedAugust 24, 2015
Recall Status1 Terminated 3 on March 11, 2016
Recall NumberZ-2453-2015
Recall Event ID 71826
Product Classification Reagents,specific,analyte - Product Code MVU
ProductBD 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
FEI Number 2916837
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company, BD Biosciences
2350 Qume Dr
San Jose CA 95131-1812
For Additional Information ContactEric 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
ActionBD 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 Commerce362 units
DistributionUS Distribution and Internationally to Taiwan.
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.
-
-