Z-2381-2021 Class II Terminated
FDA device recall Z-2381-2021 was initiated by Thera Test Laboratories, Inc. on July 30, 2020 and is designated Class II. Reason for recall: Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129 The recall status is terminated (terminated February 15, 2022). Affected quantity: 11 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- July 30, 2020
- Termination Date
- February 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 kits
Product Description
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 Pattern
US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.
Code Information
Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021.