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U.S. Department of Health and Human Services

Class 1 Device Recall RNAstill MTM

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  Class 1 Device Recall RNAstill MTM see related information
Date Initiated by Firm January 10, 2022
Create Date February 17, 2022
Recall Status1 Completed
Recall Number Z-0568-2022
Recall Event ID 89374
Product Classification Microbial nucleic acid storage and stabilization device - Product Code QBD
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.
Code Information Catalog #MTM-SW03: Lot numbers MG18401, MG18409, HH04806, KM02643, MG27906, MG28502,MG30295, and MG33903.  Catalog #MTM-SW05: Lot numbers MG18401, MG18408, MG27901, and KC28836.
Recalling Firm/
70 E Lake St Ste 226
Chicago IL 60601-7650
For Additional Information Contact Jaymie Wertz
Manufacturer Reason
for Recall
The product does not have 510(k) clearance.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.