BASE 10 GENETICS INC: 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.

Recall number

Z-0568-2022

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.

Status

Terminated

Initiated

2022-01-10

Posted

not on file

Terminated

2024-09-27

Reason

The product does not have 510(k) clearance.

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

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.

Lot, serial or model codes

Catalog #MTM-SW03: Lot numbers MG18401, MG18409, HH04806, KM02643, MG27906, MG28502,MG30295, and MG33903.  Catalog #MTM-SW05: Lot numbers MG18401, MG18408, MG27901, and KC28836.

510(k) numbers

not on file

PMA numbers

not on file

Product code

QBD

Firm FEI

3016814582

Firm city

Chicago

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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