FDA Enforcement
Class II
Terminated
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Recall: Z-2382-2021
·
Reported September 8, 2021
Enforcement
- Recall Number
- Z-2382-2021
- Event ID
- 88478
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Thera Test Laboratories, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 8, 2021
- Initiation Date
- October 5, 2020
- Classification Date
- August 27, 2021
- Termination Date
- February 15, 2022
- Address
- 1120 N Du Page Ave, N/A, Lombard, IL, 60148-1247, United States
Description
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Reason
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Code Info
Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021.
Distribution
US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
Quantity
19 kits