Recall Z-1496-2018— Diagnostic Hybrids, Inc.

Name: FDA recall Z-1496-2018
Creator: U.S. Food and Drug Administration
Published: 2017-04-04

Class II · Terminated

Class II FDA medical device recall by Diagnostic Hybrids, Inc., initiated 2017-04-04, terminated 2020-08-28. It names one FDA 510(k) clearance: K862649. 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..

Recalling firm: Diagnostic Hybrids, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-04
Terminated: 2020-08-28
Firm location: Athens, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K862649 — CYTOTECH CIC ENZYME IMMUNOASSAYCytotech, Inc.·cleared 1986-09-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.