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U.S. Department of Health and Human Services

Class 2 Device Recall BD Affirm VPIII Microbial Identification Tests

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  Class 2 Device Recall BD Affirm VPIII Microbial Identification Tests see related information
Date Initiated by Firm August 27, 2015
Date Posted February 27, 2017
Recall Status1 Terminated 3 on March 06, 2017
Recall Number Z-1394-2017
Recall Event ID 76492
510(K)Number K931374  
Product Classification Dna probe, yeast - Product Code MLA
Product BD AffirM VPIII Microbial Identification Test
Code Information Catalog Number Batch Number  446252 5126980  5135673  5138774  5140625  5142767  5153674  5153675  5224882  446257 5141655  5148857  5156873  5173648 
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
BD Diagnostic Systems
Sparks MD 21152-9212
For Additional Information Contact BD
410-316-4000
Manufacturer Reason
for Recall		 BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.
FDA Determined
Cause 2		 Employee error
Action Becton Dickinson sent an Urgent Product Recall Letter dated August 2015. The distributors were provided with a written communication via email and customers were provided with a written communication via UPS. Customers were not asked to send product back. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663. For further questions please call (410) 316-4428.
Quantity in Commerce Qty Distributed to Field - 4,502
Distribution Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and to the countries of : AU, BE, IN, KR, SG,
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 = MLA and Original Applicant = MICROPROBE CORP.
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