Z-0568-2022 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 23, 2022
- Initiation Date
- January 10, 2022
- Termination Date
- September 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 455,791 kits
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.
Reason for Recall
The product does not have 510(k) clearance.
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.
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.