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 ImmunoPass COVID-19 Neutralizing Antibody Rapid Test uses a fingerstick blood sample to detect antibodies produced by a person’s immune system in response to SARS-CoV-2. If antibodies are found it means the person may previously have been infected with the SARS-CoV-2 virus. Antibody tests should not be used to diagnose or exclude an

SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) SARS-CoV-2 Antigen Rapid Test Kit; SKIPPACK COVID-19 Antigen Home Test; SML LDT Kits; SML Brand: Finished Kits; BT Test

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 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

Anyone who received the CovClear COVID-19 Rapid Antigen Test in the last two weeks is urged by the FDA to get tested again. The tests were distributed from January to November 2021. According to

Oct 06,  · An Australian company issued a recall of nearly 200,000 at-home rapid COVID-19 tests, over concerns some of the kits may result in false positives. The recall would affect

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

Date Recall Initiated by Firm: December 22, Test Use The CovClear COVID-19 Rapid Antigen Test uses a nasal swab sample to detect proteins, called antigens, from SARS

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

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. In clinical