Lombard, IL, United States
Thera Test Laboratories, Inc. recalls
2 recalls recorded since 2018, most recently on 5 October 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 5 October 2020
- Terminated
- 15 February 2022
- Reason
- The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
- Distribution
- US Nationwide distribution in the states of California, Florida, Illinois, Indiana, North Carolina, and Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2382-2021
- EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Terminated Class II Medical devices
- Recall started
- 30 July 2020
- Terminated
- 15 February 2022
- Reason
- Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, IN, NC, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2381-2021
- EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.