Oct 06,  · Ellume was the first company authorized by the FDA to sell COVID-19 testing kits in stores. The rapid test kits provide results within 15 minutes and do not require a prescription.

At least 77,339 Date Initiated by Firm: March 24, Device Description The Innova SARS-CoV-2 Antigen Rapid Qualitative Test claimed to determine if a person has an active COVID-19 infection. The

The recall affects 122,175 devices distributed between March 1, , and Feb. 15, 2022. North American Diagnostics sent an email to customers and distributors on June 15 asking for any existing devices to be quarantined and immediately destroyed. American Contract Systems' COVID-19 test recall gets Class I label from FDA

The CovClear COVID-19 Rapid Antigen Test uses a nasal swab sample to detect antigens from the virus, the FDA said. The tests were distributed from January to November 2021. According to the

Recall Status 1: Completed: Recall Number: Z-0564-2022: Recall Event ID: 89485: Product Classification: Coronavirus antigen detection test system. - Product Code QKP: Product: E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit: Code Information: Lot numbers are unavailable.

Class 1 Device Recall INNOVA SARSCoV2 Antigen Rapid Qualitative Test. Coronavirus antigen detection test system. INNOVA MEDICAL GROUP, INC. Due to distributing test kits to customers who were not part of a clinical investigation. On or about 04/26/ , the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification via email to its customers

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FDA issued two Class 1 Device Recalls, the most serious type of recall, for the Celltrion DiaTrust™ COVID-19 Ag Rapid Test, Reference Number CT-P60 D-2 02. FDA initially authorized this test on April 16, for use at the point-of-care (POC) such as health clinics and congregate settings.

Nov 12,  · Nov 12, - 11:01 AM. Ellume has expanded its recall of rapid at-home COVID-19 antigen tests to about 2 million tests, the Food and Drug Administration said in an update

The CovClear COVID-19 Rapid Antigen Test uses a nasal swab sample to detect antigens from the virus, the FDA said. The tests were distributed from January to November 2021. According to the

The Food and Drug Administration labeled another COVID-19 rapid antigen test as a Class I event, assigning the highest risk category to SML Distribution’s withdrawal of 209,450 unauthorized products. SML began contacting its customers by phone in March and went on to email a recall notice later that month. The letter explains that SML is