Home / Recalls / Diagnostic Hybrids, Inc. / Z-1497-2018

Z-1497-2018 Class III Terminated

Recalled by Diagnostic Hybrids, Inc. — Athens, OH

Recall Details

Product Type
Devices
Report Date
May 2, 2018
Initiation Date
November 3, 2015
Termination Date
August 28, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 kits

Product Description

MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.

Reason for Recall

A component of the kit was found to contain bacterial contamination.

Distribution Pattern

Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.

Code Information

Lot 051076

Other recalls by Diagnostic Hybrids, Inc.

  • Z-1496-2018 Class II — MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of ci (April 4, 2017)
  • 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-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)