Z-1812-2013 Class II Terminated
FDA device recall Z-1812-2013 was initiated by Becton Dickinson & Co. on Jun 13, 2013 and is designated Class II. Reason for recall: In vitro diagnostic test kit may exhibit invalid internal negative control results. The recall status is terminated (terminated Sep 28, 2013). Affected quantity: 177 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 7, 2013
- Initiation Date
- Jun 13, 2013
- Termination Date
- Sep 28, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 177 kits
Product Description
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,
Reason for Recall
In vitro diagnostic test kit may exhibit invalid internal negative control results.
Distribution Pattern
Nationwide Distribution
Code Information
Cat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1812-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026