MicroVue SC5b-9 Plus EIA — Class III medical device recall Z-1498-2018
Terminated recall by Diagnostic Hybrids, Inc., reported 2018-05-02, distributed nationwide. A component of the kit was found to contain bacterial contamination.
| Recall number | Z-1498-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostic Hybrids, Inc., Athens, OH, United States |
| Recall initiated | 2015-11-03 |
| Classified | 2018-04-24 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, HK, IN, JP |
| Quantity | 107 kits |
| Reason classes | microbial contamination |
| Lot numbers | 052418 |
| Model numbers | A020 |
Product
MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Reason for recall
A component of the kit was found to contain bacterial contamination.
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-1498-2018. 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.