FDA Device recall Z-2381-2021
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
- 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 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 by Thera Test Laboratories, citing device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2381-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-30 |
| Published | 2021-09-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Thera Test Laboratories |
| Distribution | US |
Product
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
Identifiers
| code_info | Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, 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-2381-2021%22
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