Becton Dickinson & Co.: Medical Device Recall in 2017 - (Recall #: Z-1394-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

BD AffirM VPIII Microbial Identification Test

Product Classification:

Class II

Date Initiated: August 27, 2015

Date Posted: March 8, 2017

Recall Number: Z-1394-2017

Event ID: 76492

Reason for Recall:

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.

Status: Terminated

Product Quantity: Qty Distributed to Field - 4,502

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,

Voluntary or Mandated:

Voluntary: Firm initiated