FDA Device recall Z-2382-2021
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130
- FDA Device
- Class II
- terminated
- Published 2021-09-08
On 2021-09-08 the FDA classified a Class II recall of EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130 by Thera Test Laboratories, citing the cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2382-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-05 |
| Published | 2021-09-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Thera Test Laboratories |
| Distribution | US |
Product
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
Identifiers
| code_info | Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2382-2021%22
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