Friday, February 18, 2022

BASE10 Genetics Recalls RNAstill MTM Specimen Kits Not Cleared by the FDA

Serious injuries or death may result from the use of these devices. This is a Class I recall, the most serious type of recall.

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CDRH Medical Device Recall

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BASE10 Genetics Recalls RNAstill MTM Specimen Collection Kits That Are Not Authorized, Cleared, or Approved by the FDA, May Give False Results, and Require Special Training for Safe Handling

BASE10 Genetics is recalling the RNAstill MTM specimen collection kits because they were distributed without proper premarket clearance from the FDA—meaning there is not adequate data available about this product to know that it performs as intended.

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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.

Questions?

If you have questions about this recall, contact info@base10genetics.com or call 1-866-710-1018.


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