Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported February 23, 2022
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 product does not have 510(k) clearance.
Base 10 Genetics INC recalled RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the foll… - a critical-severity action.
RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the foll… was recalled by Base 10 Genetics INC in February 23, 2022. Reason: The product does not have 510(k) clearance.. Check the official notice for the remedy. Verify recall #Z-0568-2022 with the FDA Devices before acting.
The recall
Base 10 Genetics INC issued this critical-severity FDA Devices recall-The product does not have 510(k) clearance..
- Critical
- severity level
- Class I
- classification
- February 23, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0568-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0568-2022) was formally reported on February 23, 2022, with the manufacturer initiating the action on January 10, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. Base 10 Genetics INC is listed as the recalling firm, operating out of Chicago, IL. Federal records list the affected scope as 455,791 kits.
The documented reason for this recall is: The product does not have 510(k) clearance. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
455,791 kits
Related Recalls
6
6 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0568-2022 |
| Date reported | February 23, 2022 |
| Date initiated | January 10, 2022 |
| Recalling firm | Base 10 Genetics INC |
| Firm location | Chicago, IL |
| Affected scope | 455,791 kits |
| 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0568-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Base 10 Genetics INC. Units affected: 455,791 kits.
Why was this product recalled? ▼
The product does not have 510(k) clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 23, 2022. Severity: Critical. Recall number: Z-0568-2022.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0568-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 23, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.