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Base10 Genetics Recalls Specimen Collection Kit for Viral Testing

NEW YORK – The US Food and Drug Administration announced on Friday that Base10 Genetics is recalling its RNAstill MTM specimen collection kit.

Base10's specimen collection kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal or oropharyngeal swab samples to be tested for viruses, including SARS-CoV-2, influenza, and bacteria, the FDA said in the recall notice posted to its website.

The Class I recall — the most serious type of recall due to the potential of serious injury or death — was issued because Base10's kits were distributed without proper premarket clearance from the FDA, so there is not enough data available about the product to know how well it inactivates and stabilizes a virus for transport and storage. If the specimens aren't stored correctly, it could lead to false negative results or the virus spreading to people in the lab. 

The kits were distributed to long-term care facilities where staff may not have been trained to handle the transport medium of the kit, which contains a hazardous chemical requiring special training, the FDA said on its website.

The company and agency recommend discontinuing use and returning the unused product. The agency noted that the medium shouldn't come into contact with bleach or other oxidizing agents or acidic or alkaline products in order to prevent the release of toxic gases.

The FDA also issued a notice on Friday that E25Bio is recalling its COVID-19 Direct Antigen Rapid Test, as reported by 360Dx.

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