Recall Z-1812-2013 ยท MLA Dna Probe, Yeast
Becton Dickinson & Co.
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
| Date | Jul 26, 2013 (initiated Jun 13, 2013) |
| Status | Terminated |
| Reason | In vitro diagnostic test kit may exhibit invalid internal negative control results. |
| 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, a |
| Quantity | 177 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.