Drug recall
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative…
FDA recall event 86516 · Class II · Epitope Diagnostics, Inc.
Key facts
| Event ID | 86516 |
|---|---|
| Recall numbers | Z-0426-2021 |
| Recalling firm | Epitope Diagnostics, Inc. |
| Product type | Devices |
| Products | EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value. |
| Initiation date | Oct 1, 2020 |
| Report date | Nov 18, 2020 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 3004185580 |
At a glance
- 1–9 Products in this recall
- 1–9 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: