Reported May 2, 2018 · Terminated
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human…
Diagnostic Hybrids, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnostic Hybrids, Inc. · 2005 E State St Ste 100 · Athens, OH · 45701-2125
Is this the product you have?
- 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.
- Lot codes and dates
- Lot 084007
- Amount recalled
- 101 kits
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
This product could cause temporary or reversible health problems — stop using it.
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