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.
This recall has been terminated (originally issued November 3, 2015).
- Company
- Diagnostic Hybrids, Inc.
- Recall Initiated
- November 3, 2015
- Terminated
- August 28, 2020
- Recall Number
- Z-1497-2018
- Quantity
- 19 kits
- Firm Location
- Athens, OH
- Official Source
- View on FDA website ↗
Reason for Recall
A component of the kit was found to contain bacterial contamination.
Distribution
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.
Lot / Code Info
Lot 051076
Root Cause
Material/Component Contamination
Action Taken
Customers were notified via letter dated November 3, 2015, to review their inventory for the specified lots, discard the kits, and contact the recalling firm for replacement. Certificates of destruction were also provided to customers. For further questions, please call (740) 589-3300.
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