Z-2382-2021 Class II Terminated
FDA device recall Z-2382-2021 was initiated by Thera Test Laboratories, Inc. on October 5, 2020 and is designated Class II. Reason for recall: The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128 The recall status is terminated (terminated February 15, 2022). Affected quantity: 19 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- October 5, 2020
- Termination Date
- February 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 kits
Product Description
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 Pattern
US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
Code Information
Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021.