BD Affirm VPIII Microbial Identification Tests — Class II medical device recall Z-1812-2013
Terminated recall by Becton Dickinson & Co., reported 2013-08-07, distributed nationwide. In vitro diagnostic test kit may exhibit invalid internal negative control results.
| Recall number | Z-1812-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2013-06-13 |
| Classified | 2013-07-26 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2013-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 177 kits |
| Lot numbers | 3035126, 3065261, 446252 |
| Model numbers | 446252, 446257 |
| Expiration dates | 2013-08-31, 2013-12-04 |
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,
Reason for recall
In vitro diagnostic test kit may exhibit invalid internal negative control results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1812-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.