BASE 10 GENETICS INC: Medical Device Recall in 2022 - (Recall #: Z-0568-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: January 10, 2022

Date Posted: February 23, 2022

Recall Number: Z-0568-2022

Event ID: 89374

Reason for Recall:

The product does not have 510(k) clearance.

Status: Terminated

Product Quantity: 455,791 kits

Code Information:

Catalog #MTM-SW03: Lot numbers MG18401, MG18409, HH04806, KM02643, MG27906, MG28502,MG30295, and MG33903. Catalog #MTM-SW05: Lot numbers MG18401, MG18408, MG27901, and KC28836.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated