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Recall Observatory FDA recall evidence

Device product

BD AffirM VPIII Microbial Identification Test

Z-1394-2017

August 27, 2015

Class II

Product summary

Firm
Becton Dickinson & Co.
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

    reason.no_named_rule · v1.0.0

    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.