Device 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,
Z-1812-2013
Product summary
- Event
- Event 65619
- Status
- Terminated
- Classification
- Class II
- Quantity
- 177 kits
- Official record key
device-enforcement:Z-1812-2013
Official wording
Reason: In vitro diagnostic test kit may exhibit invalid internal negative control results.
Code information: Cat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
In vitro diagnostic test kit may exhibit invalid internal negative control results.