MicroVue CIC-C1q EIA — Class II medical device recall Z-1496-2018
Terminated recall by Diagnostic Hybrids, Inc., reported 2018-05-02, distributed in CO, NY, TX, UT. There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for
| Recall number | Z-1496-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostic Hybrids, Inc., Athens, OH, United States |
| Recall initiated | 2017-04-04 |
| Classified | 2018-04-24 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-08-28 |
| Distributed | CO, NY, TX, UT |
| Countries outside the US | CH |
| Quantity | 101 kits |
| Reason classes | potency |
| Lot numbers | 084007 |
| Model numbers | A001 |
Product
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.
Reason for recall
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
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-1496-2018. 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.