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U.S. Department of Health and Human Services

Class 2 Device Recall BD Affirm VPIII Microbial Identification Tests

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  Class 2 Device Recall BD Affirm VPIII Microbial Identification Tests see related information
Date Initiated by Firm June 13, 2013
Date Posted July 26, 2013
Recall Status1 Terminated 3 on September 28, 2013
Recall Number Z-1812-2013
Recall Event ID 65619
Product Classification Dna probe, yeast - Product Code MLA
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,
Code Information Cat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13 
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Ms. Gail Claiborne
410-316-4054
Manufacturer Reason
for Recall		 In vitro diagnostic test kit may exhibit invalid internal negative control results.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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