Z-0568-2022Class I

RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog...

Name: Z-0568-2022 RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog...
Creator: Base 10 Genetics Inc
Published: 2022-01-10
License: https://open.fda.gov/license/

Base 10 Genetics Inc / initiated 2022-01-10 / Terminated

FDA source

BASE 10 GENETICS INC began a recall of RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits... on 2022-01-10. FDA classified it as Class I and gives the reason as "The product does not have 510(k) clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0568-2022
Classification: Class I
Status: Terminated
Initiated: 2022-01-10
Posted: 2022-02-17
Terminated: 2024-09-27
Recalling firm: Base 10 Genetics Inc
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.
Product code: QBD Microbial Nucleic Acid Storage And Stabilization Device
Reason for recall: The product does not have 510(k) clearance.
FDA root cause: No Marketing Application
Action: The recalling firm issued letters dated 1/10/2022 to the main office locations of the end-user facilities explaining the reason for recall, hazard involved, and requesting they discontinue use per their instruction on 11/30/2021. (The main office locations were only instructed to discontinue use at that time and the product was not under recall then.) The letter requested return of the kits as soon as possible and the firm's Client Success team will contact the end-user facilities to provide detailed instructions to complete and return. An Acknowledgement and Receipt Form was enclosed for completion and return via email to the firm. The Client Success Team began sending follow-up emails to the end-user facilities on 1/11/2022 which provided the number of kits the firm should have and that they should be returned by 1/21/2022. Attached was a return shipping label and a guide with additional details on how to return the kits. The follow-up email also contained the reason for recall and hazard involved. The home office for the end-user facilities sent out emails beginning 1/11/2022 to their end-user facilities containing the subject line "COVID-19 UPDATE: Base10 Test Kit Recall Instructions." The email contained an advisory which said facilities should not be discarding old Base10 test kits that were discontinued for use. It also said that Base 10 will be performing a recall on all RBC Kits beginning today and the end user will receive formal notification from Base 10 as well. Return instructions were sent with the email.
Quantity in commerce: 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.
Product codes and lots: Catalog #MTM-SW03: Lot numbers MG18401, MG18409, HH04806, KM02643, MG27906, MG28502,MG30295, and MG33903. Catalog #MTM-SW05: Lot numbers MG18401, MG18408, MG27901, and KC28836.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0568-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0568-2022	Class I	Terminated	Voluntary: Firm initiated	2022-02-23	2022-02-17

Product code QBD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)