# FDA recall Z-0426-2021

> **Epitope Diagnostics, Inc.** · Class II · device recall initiated 2020-10-01.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0426-2021
- **Recalling firm:** Epitope Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-10-01
- **Report date:** 2020-11-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0426-2021

## Citation

> AI Analytics. FDA recall Z-0426-2021. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-0426-2021. Source: US FDA. Licensed CC0.

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