FDAClass IIAugust 7, 2013

BD Affirm VPIII Microbial Identification Tests recall

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,

Why was BD Affirm VPIII Microbial Identification Tests recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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,
Recalling firm
Becton Dickinson & Co.
Quantity
177 kits
Distribution
Nationwide Distribution
Recall date
August 7, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls