BD AffirM VPIII Microbial Identification Test
This recall has been terminated (originally issued February 27, 2017).
- Recall Initiated
- August 27, 2015
- Posted
- February 27, 2017
- Terminated
- March 6, 2017
- Recall Number
- Z-1394-2017
- Quantity
- Qty Distributed to Field - 4,502
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
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.
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,
Lot / Code Info
Catalog Number Batch Number 446252 5126980 5135673 5138774 5140625 5142767 5153674 5153675 5224882 446257 5141655 5148857 5156873 5173648
Root Cause
Employee error
Action Taken
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.