# FDA recall Z-0568-2022

> **BASE 10 GENETICS INC** · Class I · device recall initiated 2022-01-10.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0568-2022
- **Recalling firm:** BASE 10 GENETICS INC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-10
- **Report date:** 2022-02-23
- **Termination date:** 2024-09-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0568-2022

## Citation

> AI Analytics. FDA recall Z-0568-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0568-2022. Source: US FDA. Licensed CC0.

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