Reported Feb 23, 2022 · Terminated

RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of…

Base 10 Genetics Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BASE 10 GENETICS INC · 70 E Lake St Ste 226 · Chicago, IL · 60601-7650

Is this the product you have?

  • RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of
  • RNAstill MTM specimen collection kitsMTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve. RNAstill Molecular Transport Medium (MTM) safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing safe transport of specimens at ambient temperature from the collection site to the laboratory with no need for dry ice and no need for special containment facilities
Lot codes and dates
  • Catalog #MTM-SW03: Lot numbers MG18401, MG18409, HH04806, KM02643, MG27906, MG28502,MG30295, and MG33903. Catalog #MTM-SW05: Lot numbers MG18401, MG18408, MG27901, and KC28836.
Amount recalled
455,791 kits

Where it was sold

Why it was recalled

Stop using this product now

The product does not have 510(k) clearance.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 27, 2024 · Data as of Sep 19, 5:37 PM UTC

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