Recall Z-2381-2021— Thera Test Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Thera Test Laboratories, Inc., initiated 2020-07-30, terminated 2022-02-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- Thera Test Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-30
- Terminated
- 2022-02-15
- Firm location
- Lombard, IL, United States
Product description
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Reason for recall
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
Data sourced from openFDA. This site is unofficial and independent of the FDA.