Drug recall
MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes…
FDA recall event 79642 · Class III · Diagnostic Hybrids, Inc.
Key facts
| Event ID | 79642 |
|---|---|
| Recall numbers | Z-1497-2018, Z-1498-2018, Z-1499-2018 |
| Recalling firm | Diagnostic Hybrids, Inc. |
| Product type | Devices |
| Products | 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…, MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum., MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A component of the kit was found to contain bacterial contamination. |
| Initiation date | Nov 3, 2015 |
| Report date | May 2, 2018 |
| Termination date | Aug 28, 2020 |
| City | Athens |
| State | OH |
| Country | United States |
| FEI number | 1000122536 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: