RNAstill Molecular Transport Medium Vial — Class I medical device recall Z-0568-2022
Terminated recall by BASE 10 GENETICS INC, reported 2022-02-23, distributed nationwide. The product does not have 510(k) clearance.
| Recall number | Z-0568-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BASE 10 GENETICS INC, Chicago, IL, United States |
| Recall initiated | 2022-01-10 |
| Classified | 2022-02-17 |
| Reported by FDA | 2022-02-23 |
| Terminated | 2024-09-27 |
| Distributed | Nationwide (US) |
| Quantity | 455,791 kits |
| Lot numbers | HH04806, KC28836, KM02643, MG18401, MG18408, MG18409, MG27901, MG27906, MG28502, MG30295, MG33903 |
| Model numbers | MTM-001, MTM-SW03, MTM-SW05 |
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 for recall
The product does not have 510(k) clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0568-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.