FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Check against the official notice below — it lists the full affected range.
Migo Trading LLC is recalling Flowflex SARS-COV-2 Antigen Rapid Test (Self-Testing) kits because the devices do not comply with the firm's Emergency Use Authorization (EUA) from the FDA. The product has not been authorized for emergency use, and the test cannot be confirmed to be adequately validated for its intended use. Approximately 200,100 units were distributed in New York.
The recall affects two lot codes: COV1080232 (expiring 05/13/2023) and COV1095004 (expiring 09/03/2023), identifiable by the UDI number 6921756492427. The source document does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use.
Reason for recall: Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use. Distribution: NY Quantity: 200,100 units Lot/code info: UDI #: 6921756492427 Lot codes: COV1080232 - Expiration date: 05/13/2023; COV1095004 - Expiration date: 09/03/2023
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.