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Thera Test Laboratories Recalls
2 recalls on record · September 8, 2021 to September 8, 2021 · Medical Devices
September 8, 2021Medical DevicesFDA
Thera Test Laboratories, Inc. recalls EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Hazard: The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
September 8, 2021Medical DevicesFDA
Thera Test Laboratories, Inc. recalls EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Hazard: Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as EUA202129