FDA Medical Device Recalls (openFDA)
Thera Test Laboratories, Inc.: EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
- Recall number
- Z-2382-2021
- Recalling firm
- Thera Test Laboratories, Inc.
- Product
- EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
- Status
- Terminated
- Initiated
- 2020-10-05
- Posted
- not on file
- Terminated
- 2022-02-15
- Reason
- The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
- Root cause
- No Marketing Application
- Action
- The firm initiated the recall using undated letters attached to emails sent on 10/7/2020 requesting return of product.
- Quantity
- 19 kits
- Distribution
- US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
- Lot, serial or model codes
- Lot numbers 05204351, exp. 5/1/2021, and 05204368, exp. 05/19/2021.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKO
- Firm FEI
- 1421346
- Firm city
- Lombard
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28