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BASE 10 GENETICS INC recalls RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAsti
Recalled February 23, 2022 · FDA recall Z-0568-2022 · BASE 10 GENETICS
Hazard
The product does not have 510(k) clearance. · FDA Class I
Units
455,791 kits
Sold at
US Nationwide distribution in the states of AL, CO, FL, GA, ID, IN, KY, MD, NC, NV, NY, OH, OR, TN, UT, VA, WA, and WV.
Description
The product does not have 510(k) clearance.
Product
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-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.
Manufacturer(s)
BASE 10 GENETICS INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →