Recalls · Brand

Epitope Diagnostics, Inc. recalls

Every recall we track for Epitope Diagnostics, Inc. — 1 in all, all from 2020 — plus the complaints and injury reports the public filed about them.

1recalls

Recalls per year, by danger level

1 recall since 2017.

All FDA recall records for Epitope Diagnostics, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for Epitope Diagnostics, Inc., by danger level
Year	Lower risk	Total
2017	0	0
2018	0	0
2019	0	0
2020	1	1
2021	0	0
2022	0	0
2023	0	0
2024	0	0
2025	0	0
2026 (to date)	0	0

What to do if you have a recalled Epitope Diagnostics, Inc. product

Match the model, catalog or lot number on your device to the recall.
Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
Report problems to FDA MedWatch.

See this week’s new recalls.

All Epitope Diagnostics, Inc. recalls

1 shown

Lower riskMedical device
Epitope Diagnostics, Inc. recalls EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of
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.
Epitope DiagnosticsOct 1, 2020

Epitope Diagnostics, Inc. recall questions

How many recalls has Epitope Diagnostics, Inc. had?

1 recall from Epitope Diagnostics, Inc. are on record with U.S. safety agencies, from 2020.

What is the most recent Epitope Diagnostics, Inc. recall?

Epitope Diagnostics, Inc. recalls EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of, dated Oct 1, 2020. Every Epitope Diagnostics, Inc. recall is listed on this page, newest first.

What should I do if I have a recalled Epitope Diagnostics, Inc. product?

Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.

How do I get alerts for new Epitope Diagnostics, Inc. recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.