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Diagnostic Hybrids, Inc. recalls MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in
Recalled May 2, 2018 · FDA recall Z-1499-2018 · Diagnostic Hybrids
Hazard
A component of the kit was found to contain bacterial contamination. · FDA Class III
Units
72 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 SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
Manufacturer(s)
Diagnostic Hybrids, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →