Z-0426-2021Class II

EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative...

Name: Z-0426-2021 EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative...
Creator: Epitope Diagnostics, Inc.
Published: 2020-10-01
License: https://open.fda.gov/license/

Epitope Diagnostics, Inc. / initiated 2020-10-01 / Open, Classified / root cause: manufacturing process

FDA source

Epitope Diagnostics, Inc. began a recall of 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... on 2020-10-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0426-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-10-01
Posted: 2020-11-06
Recalling firm: Epitope Diagnostics, Inc.
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.
Product code: QKO Reagent, Coronavirus Serological
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 10/01/20, the firm, Epitope Diagnostics Inc. (EDI), sent "URGENT: EDI" Novel Coronavirus COVID-19 IgG ELISA Kit Recall" notices were sent to customers. Customers were asked to do the following: Results where the assay controls do not meet the manufacturer's defined specifications should be considered invalid and repeated with another lot. Immediately examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Complete and promptly return the Customer Response Form by Email to: [email protected] or Fax to: 858-693-7877. Your notification to your customers may be enhanced by including a copy of this recall notification letter. For customers located within United States, we will ask that you return this affected product to the recalling firm. For customers located outside United States, please destroy the affected product. For any questions, please refer to EDIs Quality Assurance and Regulatory Affairs Manager, Stefanie Dallezotte, by email: [email protected] or by telephone: +1 858 693 7877.
Quantity in commerce: 2886
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.
Product codes and lots: Lot Numbers: P826, P815, P796, P776

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0426-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0426-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-18	2020-11-06

Product code QKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)