BD AffirM VPIII Microbial Identification Test — Class II medical device recall Z-1394-2017
Terminated recall by Becton Dickinson & Co., reported 2017-03-08, distributed nationwide. BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may
| Recall number | Z-1394-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2015-08-27 |
| Classified | 2017-03-02 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2017-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 4,502 |
| Lot numbers | 446252, 446257, 5126980, 5135673, 5138774, 5140625, 5141655, 5142767, 5148857, 5153674, 5153675, 5156873, 5173648, 5224882 |
Product
BD AffirM VPIII Microbial Identification Test
Reason for recall
BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.
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-1394-2017. 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.