Thera Test Laboratories, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2382-2021)

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 IgG Kit, Catalog #104-130. Submitted as EUA202128

Product Classification:

Class II

Date Initiated: October 5, 2020

Date Posted: September 8, 2021

Recall Number: Z-2382-2021

Event ID: 88478

Reason for Recall:

The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128

Status: Terminated

Product Quantity: 19 kits

Code Information:

Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021.

Distribution Pattern:

US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.

Voluntary or Mandated:

Voluntary: Firm initiated