FDA recall Z-2382-2021

Thera Test Laboratories, Inc. · Class II · device

Product

EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-10-05
Report date
2021-09-08
Termination date
2022-02-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lombard, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2382-2021