Recall Z-1496-2018 ยท DAK Complement C1q, Antigen, Antiserum, Control
Diagnostic Hybrids, Inc.
MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation
| Date | Apr 4, 2017 |
| Status | Terminated |
| Reason | There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay. |
| Root cause | Other |
| Action | Customers were notified via letter on 4/4/17. Customers were asked to review their current inventory for the specified lot and complete and return the response form. If the product was further distributed, customers were instructed to provide them with the notification letter. |
| Quantity | 101 kits |
| Distribution | The products were distributed to the following US states: NY, TX, CO, UT. The products were distributed to the following foreign countries: Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862649 | CYTOTECH CIC ENZYME IMMUNOASSAY Cytotech, Inc., Sep 4, 1986 |