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.
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.
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.
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.
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.
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.
Look for the lot number on the kit label; affected lots are P826, P815, P796, and P776.
The recall is because using deionized water instead of distilled water during manufacturing may cause the test to give inaccurate results, specifically reduced optical density signals for the Positive Control value.
Check the lot number on the kit label. If it's one of the affected lots (P826, P815, P796, P776), you may want to contact Epitope Diagnostics for guidance.
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.
We’ve drafted a message you can send Epitope Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0426-2021 — Epitope Diagnostics Epitope Diagnostics Hello, I own a Epitope Diagnostics that is covered by recall Z-0426-2021 from Epitope Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
