Recall Z-2382-2021— Thera Test Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Thera Test Laboratories, Inc., initiated 2020-10-05, terminated 2022-02-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- Thera Test Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-05
- Terminated
- 2022-02-15
- Firm location
- Lombard, IL, United States
Product description
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Reason for recall
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Data sourced from openFDA. This site is unofficial and independent of the FDA.