Z-2381-2021Class II

EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129

Name: Z-2381-2021 EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Creator: Thera Test Laboratories, Inc.
Published: 2020-07-30
License: https://open.fda.gov/license/

Theratest Laboratories, Inc. / initiated 2020-07-30 / Terminated

FDA source

Thera Test Laboratories, Inc. began a recall of EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 on 2020-07-30. FDA classified it as Class II and gives the reason as "Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2381-2021
Classification: Class II
Status: Terminated
Initiated: 2020-07-30
Posted: 2021-08-27
Terminated: 2022-02-15
Recalling firm: Theratest Laboratories, Inc.
Product: EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
FDA root cause: No Marketing Application
Action: An undated letter was issued to their customers attached to an email dated 7/30/2020 explaining the reason for recall and requesting the customer stop testing with the kit.
Quantity in commerce: 11 kits
Distribution: US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.
Product codes and lots: Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2381-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2381-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-27

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)