FDA Device recall Z-1496-2018
MicroVue CIC-C1q EIA, Model A001
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of MicroVue CIC-C1q EIA, Model A001 by Diagnostic Hybrids, citing there is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1496-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-04 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Diagnostic Hybrids |
| Distribution | CO, NY, TX, UT |
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
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
Identifiers
| code_info | Lot 084007 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1496-2018%22
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