Z-1812-2013Class II

BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24...

Name: Z-1812-2013 BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24...
Creator: Becton Dickinson & Co.
Published: 2013-06-13
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-06-13 / Terminated

FDA source

Becton Dickinson & Co. began a recall of 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... on 2013-06-13. FDA classified it as Class II and gives the reason as "In vitro diagnostic test kit may exhibit invalid internal negative control results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1812-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-13
Posted: 2013-07-26
Terminated: 2013-09-28
Recalling firm: Becton Dickinson & Co
Product: 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 code: MLA Dna Probe, Yeast
Reason for recall: In vitro diagnostic test kit may exhibit invalid internal negative control results.
FDA root cause: Under Investigation by firm
Action: Becton Dickinson Diagnostic Systems notified distributors by fax on June 13, 2013, and advised consignees to discontinue use and discard affected product for credit. Distributors were requested to return their distribution list to BD for direct notification by the recaller. End users were contacted by letter on June 13, 2013 and the notification addressed to Microbiology Lab Director/Risk Managers advised that a small number of tests associated with the referenced lots of product may exhibit invalid internal negative control results. If encountered, the issue would result in an invalid test, as described in the package insert. End users were requested to discontinue use of these lot numbers, discard any remaining packages for replacement and return the enclosed response form. Customers with questions were instructed to contact BD Technical Services Department at 1-800-638-8663. For assistance regarding replacements customers were instructed to contact BD Customer Service at 1-800-675-0908. For questions regarding this recall call 410-316-4054.
Quantity in commerce: 177 kits
Distribution: Nationwide Distribution
Product codes and lots: Cat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1812-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1812-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-26

Product code MLA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)