FDA Device recall Z-1394-2017
BD AffirM VPIII Microbial Identification Test
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of BD AffirM VPIII Microbial Identification Test by Becton Dickinson And, citing 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 bel….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1394-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-27 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD AffirM VPIII Microbial Identification Test
Reason
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.
Identifiers
| code_info | Catalog Number Batch Number 446252 5126980 5135673…Catalog Number Batch Number 446252 5126980 5135673 5138774 5140625 5142767 5153674 5153675 5224882 446257 5141655 5148857 5156873 5173648 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1394-2017%22
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