Class 2 Device Recall BD Affirm VPIII Microbial Identification Tests

• Date Initiated by Firm: August 27, 2015
• Date Posted: February 27, 2017
• Recall Status: Terminated 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: 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