Device product
BD AffirM VPIII Microbial Identification Test
Z-1394-2017
Product summary
- Event
- Event 76492
- Status
- Terminated
- Classification
- Class II
- Quantity
- Qty Distributed to Field - 4,502
- Official record key
device-enforcement:Z-1394-2017
Official wording
Reason: 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.
Code information: Catalog Number Batch Number 446252 5126980 5135673 5138774 5140625 5142767 5153674 5153675 5224882 446257 5141655 5148857 5156873 5173648
Distribution pattern: 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,
Derived failure modes
-
Unknown
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.