FDA Device recall Z-0417-2015
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test by Diagnostic Hybrids, citing samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0417-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-16 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Diagnostic Hybrids |
| Distribution | AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, WA |
Product
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Reason
Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
Identifiers
| code_info | Model Number A027; Lot Number 018186; (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0417-2015%22
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