Home / Recalls / Diagnostic Hybrids, Inc. / Z-1496-2018

Z-1496-2018 Class II Terminated

Recalled by Diagnostic Hybrids, Inc. — Athens, OH

Recall Details

Product Type
Devices
Report Date
May 2, 2018
Initiation Date
April 4, 2017
Termination Date
August 28, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
101 kits

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.

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.

Code Information

Lot 084007

Other recalls by Diagnostic Hybrids, Inc.

  • Z-1520-2018 Class III — Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quant (October 26, 2016)
  • Z-1797-2018 Class II — MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific a (July 14, 2016)
  • Z-1497-2018 Class III — MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of c (November 3, 2015)
  • Z-1499-2018 Class III — MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the qu (November 3, 2015)
  • Z-1498-2018 Class III — MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An (November 3, 2015)
  • Z-0417-2015 Class II — MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components (October 16, 2014)
  • Z-0792-2013 Class III — Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075 (December 31, 2012)