Recall Z-1497-2018 ยท DAK Complement C1q, Antigen, Antiserum, Control
Diagnostic Hybrids, Inc.
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 begi
| Date | Nov 3, 2015 |
| Status | Terminated |
| Reason | A component of the kit was found to contain bacterial contamination. |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 19 kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY Cytotech, Inc., Sep 4, 1986 |