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

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Mesa Biotech Accula False Positive COVID Test Recall Overview: 

• Who: Mesa Biotech is recalling its Accula SARS-CoV-2 Test.
• Why: Some of the tests have an increased risk of providing false positive results due to contamination at the manufacturing facility.
• Where: The recall is effective in the United States.

The U.S. Food & Drug Administration (FDA) has issued a Type 1 recall, its most serious type of recall, for lots of an Accula-brand COVID-19 test as the tests may provide false positive results.

In a recall notice posted May 9 on the FDA website, Mesa Biotech said it is recalling its Accula SARS-CoV-2 Test. 

“Certain lots of the test have an increased risk of giving false positive results due to contamination at the manufacturing facility,” the recall states. “Use of these devices may cause serious injuries or death.”

About 6,177 tests are being recalled. They have product code QJR and were distributed between Jan. 19 and Feb. 8, 2022. The specific lot numbers can be seen here. 

Covid Test Recall Says No Injuries, Adverse Health Consequences Associated With Product

The recalled PCR test is intended to detect COVID-19 based on a nasal swab sample from patients. 

The sample is collected by healthcare providers or people swabbing themselves under the guidance of a healthcare provider, the recall said.

Although there have been no reports of injuries, adverse health consequences or death associated with the use of these affected products, false positive results could lead to further exposure of uninfected individuals to SARS-CoV-2 virus, the Accula recall said.

Distributors of the test, healthcare providers who oversee the test and people who were tested using the test should be aware of the recall. 

On April 6, Mesa Biotech issued a recall letter to all known customers who received the affected lots of the Accula test. They were told to stop using test kits from the identified lots and discard or return remaining inventory from the identified lots.

The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits.

In March, consumers who bought a recalled COVID-19 test from Ellume USA LLC that threw up false positives filed a class action lawsuit against the company, alleging they did not get refunds in a timely manner.

What do you think of this recall? Let us know in the comments!

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