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Diagnostic Hybrids, Inc. recalls MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in hum
Recalled May 2, 2018 · FDA recall Z-1497-2018 · Diagnostic Hybrids
Hazard
A component of the kit was found to contain bacterial contamination. · FDA Class III
Units
19 kits
Sold at
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.
Description
A component of the kit was found to contain bacterial contamination.
Product
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.
Manufacturer(s)
Diagnostic Hybrids, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →