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Becton Dickinson & Co. recalls BD AffirM VPIII Microbial Identification Test
Recalled March 8, 2017 · FDA recall Z-1394-2017 · Becton Dickinson &
Hazard
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 Class II
Units
Qty Distributed to Field - 4,502
Sold at
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,
Description
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.
Product
BD AffirM VPIII Microbial Identification Test
Manufacturer(s)
Becton Dickinson & Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →