MicroVue BAP EIA — Class II medical device recall Z-1797-2018
Terminated recall by Diagnostic Hybrids, Inc., reported 2018-05-16, distributed in CA, CT, GA, IL, KY, MA, MD, MO…. There is a possibility of low volume and/or leaking standard bottles.
| Recall number | Z-1797-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostic Hybrids, Inc., Athens, OH, United States |
| Recall initiated | 2016-07-14 |
| Classified | 2018-05-10 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-08-28 |
| Distributed | CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, WI |
| Countries outside the US | AU, BR, CA, CH, CN, CR, IN, JP, KR, MX, PH, RU, UY, ZA |
| Quantity | 1,004 |
| Reason classes | packaging |
| Lot numbers | 067850 |
| Model numbers | 8012 |
Product
MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
Reason for recall
There is a possibility of low volume and/or leaking standard bottles.
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-1797-2018. 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.