FDA-Device2017-03-08Class II
BD AffirM VPIII Microbial Identification Test
Becton Dickinson & Co.
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.
Sold states
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,
Affected count
Qty Distributed to Field - 4,502
Manufactured in
7 Loveton Cir, BD Diagnostic Systems, Sparks, MD, United States
Products
BD AffirM VPIII Microbial Identification Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1394-2017Don't want to check this manually?
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