EDI Novel Coronavirus COVID-19 IgG ELISA Kit — Class II medical device recall Z-0426-2021
Ongoing recall by Epitope Diagnostics, Inc., reported 2020-11-18, distributed in CA, CO, FL, HI, IL, MA, MD, MI…. The use of deionized water rather than distilled water during the manufacturing process, may have resulted in
| Recall number | Z-0426-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Epitope Diagnostics, Inc., San Diego, CA, United States |
| Recall initiated | 2020-10-01 |
| Classified | 2020-11-06 |
| Reported by FDA | 2020-11-18 |
| Distributed | CA, CO, FL, HI, IL, MA, MD, MI, NC, NH, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA |
| Quantity | 2,886 |
| Lot numbers | P776, P796, P815, P826 |
| Model numbers | KT-1032 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0426-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.