Epitope Diagnostics, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0426-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 1, 2020

Date Posted: November 18, 2020

Recall Number: Z-0426-2021

Event ID: 86516

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.

Status: Ongoing

Product Quantity: 2886

Code Information:

Lot Numbers: P826, P815, P796, P776

Distribution Pattern:

U.S Distribution.: NH, CO, OR, CA, FL, NY, MD, NJ, IL, NC, MI, TX, PA, MA, OH, NM, VA, SC, HI, and TN.

Voluntary or Mandated:

Voluntary: Firm initiated