FDA Recall
Terminated
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Recall: Z-2382-2021
·
Initiated October 5, 2020
Recall
- Recall Number
- Z-2382-2021
- Event Number
- 88478
- Firm
- Thera Test Laboratories, Inc.
- FEI Number
- 1421346
- Product Code
- QKO
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- October 5, 2020
- Terminated
- February 15, 2022
- Address
- 1120 N Du Page Ave, Lombard, IL, 60148-1247
Description
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
Action
The firm initiated the recall using undated letters attached to emails sent on 10/7/2020 requesting return of product.
Distribution
US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
Quantity
19 kits