Thera Test Laboratories, Inc. EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Brand
Thera Test Laboratories, Inc.
Lot Codes / Batch Numbers
Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021.
Products Sold
Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021.
Thera Test Laboratories, Inc. is recalling EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 due to The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Recommended Action
Per FDA guidance
The firm initiated the recall using undated letters attached to emails sent on 10/7/2020 requesting return of product.
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