FDA Recall
Terminated
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Recall: Z-2381-2021
·
Initiated July 30, 2020
Recall
- Recall Number
- Z-2381-2021
- Event Number
- 88477
- Firm
- Thera Test Laboratories, Inc.
- FEI Number
- 1421346
- Product Code
- QKO
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- July 30, 2020
- Terminated
- February 15, 2022
- Address
- 1120 N Du Page Ave, Lombard, IL, 60148-1247
Description
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
Action
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.
Distribution
US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.
Quantity
11 kits