FDA Enforcement
Class II
Terminated
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Recall: Z-2381-2021
·
Reported September 8, 2021
Enforcement
- Recall Number
- Z-2381-2021
- Event ID
- 88477
- 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
- July 30, 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 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Reason
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Code Info
Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021.
Distribution
US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.
Quantity
11 kits