CLASS II Device recall · Reported 7 Aug 2013 · FDA Enforcement Report

BD Affirm Vpiii Microbial Identification Tests recalled

Becton Dickinson & is recalling BD Affirm Vpiii Microbial Identification Tests, distributed nationwide in the US. The recall was initiated on 13 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13

Quantity recalled177 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1812-2013
FDA event ID: 65619
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Terminated
Recall initiated: 13 Jun 2013
FDA classified: 26 Jul 2013
Reported: 7 Aug 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

13 Jun 2013	Recall initiated by company
26 Jul 2013	Classified by FDA	+43 days
7 Aug 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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,

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is BD Affirm Vpiii Microbial Identification Tests recalled?

Yes. Becton Dickinson & recalled BD Affirm Vpiii Microbial Identification Tests on 13 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1812-2013.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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