FDA Device recall Z-1497-2018
MicroVue CIC-C1q EIA, Model A001
- FDA Device
- Class III
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class III recall of MicroVue CIC-C1q EIA, Model A001 by Diagnostic Hybrids, citing A component of the kit was found to contain bacterial contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1497-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-11-03 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Diagnostic Hybrids |
| Distribution | US |
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.
Reason
A component of the kit was found to contain bacterial contamination.
Identifiers
| code_info | Lot 051076 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1497-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.