Thera Test Laboratories, Inc. EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Brand
Thera Test Laboratories, Inc.
Lot Codes / Batch Numbers
Kit lot numbers 05204350, exp. 05/01/2021, 05204367, exp. 05/19/2021, and 06204432, exp. 05/19/2021.
Products Sold
Kit lot numbers 05204350, exp. 05/01/2021; 05204367, exp. 05/19/2021; and 06204432, exp. 05/19/2021.
Thera Test Laboratories, Inc. is recalling EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 due to Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Recommended Action
Per FDA guidance
An undated letter was issued to their customers attached to an email dated 7/30/2020 explaining the reason for recall and requesting the customer stop testing with the kit.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026