Z-1497-2018 Class III Terminated
FDA device recall Z-1497-2018 was initiated by Diagnostic Hybrids, Inc. on November 3, 2015 and is designated Class III. Reason for recall: A component of the kit was found to contain bacterial contamination. The recall status is terminated (terminated August 28, 2020). Affected quantity: 19 kits.
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