FDA recall Z-2381-2021

Thera Test Laboratories, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-07-30
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-2381-2021