Becton Dickinson & Co.: Medical Device Recall in 2013 - (Recall #: Z-1812-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,

Product Classification:

Class II

Date Initiated: June 13, 2013

Date Posted: August 7, 2013

Recall Number: Z-1812-2013

Event ID: 65619

Reason for Recall:

In vitro diagnostic test kit may exhibit invalid internal negative control results.

Status: Terminated

Product Quantity: 177 kits

Code Information:

Cat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated