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.
FDA Recall Z-1496-2018 · Posted None
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Recalling FirmDiagnostic Hybrids, Inc.
Recall StatusTerminated
Product CodeDAK
Date Initiated2017-04-04
Date Terminated2020-08-28
Product Quantity101 kits
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.
Firm Action
Customers were notified via letter on 4/4/17. Customers were asked to review their current inventory for the specified lot and complete and return the response form. If the product was further distributed, customers were instructed to provide them with the notification letter.
Root Cause
Other
Distribution Pattern
The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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