May 11, 2022
FDA: Class I recall of certain Accula SARS-CoV-2 Tests
Editor's Note
The Food and Drug Administration (FDA) on May 9 identified the recall by Mesa Biotech, Inc, of certain Accula SARS-CoV-2 Tests as Class I, the most serious.
The recall was initiated because certain lots of the PCR test have an increased risk of giving false positive results because of contamination at the manufacturing facility.
Distribution dates were January 19 to February 8, 2022.
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