MicroVue Bb Plus EIA is packaged as a kit which contains all reagent… — Class II medical device recall Z-0417-2015
Terminated recall by Diagnostic Hybrids Inc, reported 2015-09-09, distributed in AL, CO, CT, FL, KY, MN, NC, NV…. Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously repor
| Recall number | Z-0417-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostic Hybrids Inc, Athens, OH, United States |
| Recall initiated | 2014-10-16 |
| Classified | 2015-09-03 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2015-09-03 |
| Distributed | AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, WA |
| Countries outside the US | CA, CH, CN, IN |
| Quantity | 171 |
| Lot numbers | 018186 |
| Model numbers | A027 |
Product
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Reason for recall
Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
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-0417-2015. 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.