UnratedMedical device recall · FDA · Published January 10, 2022
BASE 10 GENETICS RNAstill Vial Recall: No 510(k) Clearance
BASE 10 GENETICS recalls RNAstill Molecular Transport Medium Vials (MTM-001) due to lack of 510(k) clearance. These vials are part of specimen collection kits for swab tests. Affected lots include MG18401, MG18409, HH04806, KM02643, MG27906, MG28502, MG30295, MG33903, MG18408, MG27901, and KC28836.
📍Recalling firmBASE 10 GENETICS INC70 E Lake St Ste 226 · Chicago, IL 60601-7650
✎ GovInfoNow plain-language explainer
BASE 10 GENETICS is recalling RNAstill Molecular Transport Medium Vials (MTM-001) because they lack 510(k) clearance. This means the product has not been approved by the FDA for medical use, which could pose risks if used in clinical settings. Read more at govinfonow.com/recall/61285-base-10-genetics-rnastill-vial-recall-no-510-k-clearance.
“BASE 10 GENETICS RNAstill Vial Recall: No 510(k) Clearance.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61285-base-10-genetics-rnastill-vial-recall-no-510-k-clearance. Based on FDA recall #Z-0568-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0568-2022%22&limit=1).
BASE 10 GENETICS INC recalled RNAstill Molecular Transport Medium Vials because they lack required FDA clearance, the Food and Drug Administration said on Jan. 10, 2022.
How to tell if you have it
Brand: BASE 10 GENETICS
Product: RNAstill Molecular Transport Medium Vial, Catalog number MTM-001
Catalog #MTM-SW03 Lot numbers: MG18401, MG18409, HH04806, KM02643, MG27906, MG28502, MG30295, and MG33903
Catalog #MTM-SW05 Lot numbers: MG18401, MG18408, MG27901, and KC28836
The hazard
The product does not have 510(k) clearance.
Context
GovInfoNow's records show other recent recalls of similar products include Medline ENT Kits Recall (2026-02-25), Medline Syringes Recall (2026-02-25), and DFI One Step K In Vitro Diagnostic Test Recall (2026-04-02).
How to tell if you have this one
Check for the catalog number MTM-001 on the vial. Affected lots include MG18401, MG18409, HH04806, KM02643, MG27906, MG28502, MG30295, MG33903 for MTM-SW03 kits and MG18408, MG27901, KC28836 for MTM-SW05 kits.
Brand
BASE 10 GENETICS
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot number on the vial packaging to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 18 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Colorado, Florida, Georgia, Idaho, Indiana, Kentucky, Maryland, Nevada, New York, North Carolina, Ohio, Oregon, Tennessee, Utah, Virginia, Washington, West Virginia.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0568-2022 (January 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0568-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.