||July 26, 2013
||Terminated on September 28, 2013
|Recall Event ID
Dna probe, yeast -
||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,
||Cat #446257: Lot 3035126 Exp 12/04/13
Cat #446252: Lot 3065261 Exp 08/31/13
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
|For Additional Information Contact
||Ms. Gail Claiborne
|In vitro diagnostic test kit may exhibit invalid internal negative control results.
|Under Investigation by firm
||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
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.