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.
The product does not have 510(k) clearance.
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.
The product lacks 510(k) clearance, meaning it has not been approved by the FDA for medical use. This could lead to improper handling or potential safety issues if used in clinical settings without proper regulatory oversight.
People who purchased or use RNAstill Molecular Transport Medium Vials (MTM-001) for specimen collection kits are affected. Laboratory staff and healthcare providers using these vials for swab tests are at higher risk.
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.
Look for the lot number on the vial packaging to determine if it is affected.
The product lacks 510(k) clearance, meaning it has not been approved by the FDA for medical use.
The recall record does not specify the risk details, only that the product lacks 510(k) clearance.
Affected lots include MG18401, MG18409, HH04806, KM02643, MG27906, MG28502, MG30295, MG33903 for MTM-SW03 kits and MG18408, MG27901, KC28836 for MTM-SW05 kits.
We’ve drafted a message you can send BASE 10 GENETICS to request your refund or repair — edit it as you like.
Subject: Recall Z-0568-2022 — BASE 10 GENETICS BASE 10 GENETICS Hello, I own a BASE 10 GENETICS that is covered by recall Z-0568-2022 from BASE 10 GENETICS. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
