FDA Device recall Z-0568-2022
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen col…
- FDA Device
- Class I
- terminated
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class I recall of RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen col… by Base 10 Genetics, citing the product does not have 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0568-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-01-10 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Base 10 Genetics |
| Distribution | US |
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.
Reason
The product does not have 510(k) clearance.
Identifiers
| code_info | Catalog #MTM-SW03: Lot numbers MG18401, MG18409, HH04806, KM02643, MG27906, MG28502,MG30295, and MG33903. Catalog…Catalog #MTM-SW03: Lot numbers MG18401, MG18409, HH04806, KM02643, MG27906, MG28502,MG30295, and MG33903. Catalog #MTM-SW05: Lot numbers MG18401, MG18408, MG27901, and KC28836. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0568-2022%22
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