Thera Test Laboratories, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2381-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 30, 2020

Date Posted: September 8, 2021

Recall Number: Z-2381-2021

Event ID: 88477

Reason for Recall:

Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129

Status: Terminated

Product Quantity: 11 kits

Code Information:

Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021.

Distribution Pattern:

US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated