Epitope Diagnostics COVID-19 IgG Kit Recall: Water Quality Issue
Epitope Diagnostics recalls EDI Novel Coronavirus COVID-19 IgG ELISA Kit (KT-1032) due to potential reduced test accuracy from using deionized water instead of distilled water during manufacturing. Affected lots: P826, P815, P796, P776.
Lower-risk 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.
Contact the company
What happened, in plain English
Epitope Diagnostics is recalling their COVID-19 IgG ELISA test kits (model KT-1032) because using deionized water instead of distilled water during manufacturing might cause the test to give inaccurate results. This could lead to incorrect diagnosis of COVID-19 infections. Read more at govinfonow.com/recall/64126-epitope-diagnostics-covid-19-igg-kit-recall-water-quality-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/64126-epitope-diagnostics-covid-19-igg-kit-recall-water-quality-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0426-2021
Cite this page
“Epitope Diagnostics COVID-19 IgG Kit Recall: Water Quality Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64126-epitope-diagnostics-covid-19-igg-kit-recall-water-quality-issue. Based on FDA recall #Z-0426-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0426-2021%22&limit=1).
Why it’s dangerous
The test kit was manufactured using deionized water instead of distilled water, which can cause the Positive Control value to show reduced optical density (OD) signals. This means the test might not detect COVID-19 antibodies correctly, leading to false negative results.
Who’s affected
People who purchased the EDI Novel Coronavirus COVID-19 IgG ELISA Kit (model KT-1032) with lot numbers P826, P815, P796, or P776 are affected. Those using the kit for testing may get inaccurate results if the test is performed with deionized water instead of distilled water.
How to tell if you have this one
Check the lot number on the kit label. Affected lots are P826, P815, P796, and P776. The kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum.
- Brand
Epitope Diagnostics- Category
Medical device
What to do — step by step
Check Lot Number
Look for the lot number on the kit label; affected lots are P826, P815, P796, and P776.
Where it went and when
Where it was distributed
Distributed in 20 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Hawaii, Illinois, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia.
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Can I still use this kit?
The recall does not require immediate stopping of use, but if you have an affected lot, the test may not work correctly. Contact the manufacturer for specific advice.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0426-2021 (October 1, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0426-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.