Mesa Biotech Recalls Accula SARS-CoV-2 Tests for False Positive Risk

U.S. Food and Drug Administration sent this bulletin at 05/09/2022 11:00 AM EDT

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CDRH Medical Device Recall

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Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination

Mesa Biotech is recalling the Accula SARS-CoV-2 Test because certain lots have an increased risk of giving false positive results due to contamination at the manufacturing facility.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

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Questions?

If you have questions about this recall, contact Mesa Biotech at 1-858-800-4929, or 1-800-955-6288, option 2.