Device 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.
Z-1497-2018
Product summary
- Event
- Event 79642
- Status
- Terminated
- Classification
- Class III
- Quantity
- 19 kits
- Official record key
device-enforcement:Z-1497-2018
Official wording
Reason: A component of the kit was found to contain bacterial contamination.
Code information: Lot 051076
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.
Derived failure modes
-
Microbial contamination
bacterial contamination