Becton Dickinson & Co. recalls BD AffirM VPIII Microbial Identification Test

Recall date

August 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1394-2017

FDA classification

Class II

Brand / firm

Becton Dickinson & Co.

Sold / distributed

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 t…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD AffirM VPIII Microbial Identification Test