Class II — Epitope Diagnostics, Inc.
| Recalling firm | EPITOPE DIAGNOSTICS, INC. |
|---|---|
| Registered facility | EPITOPE DIAGNOSTICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | 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 aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection. |
| Quantity | 2886 |
| Distribution | U.S Distribution.: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN. |
| Initiated | 2020-10-01 |
| Classified | 2020-11-06 |
| Recall number | Z-0426-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Epitope Diagnostics, Inc. (Z-0426-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86516/
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