RNAstill Specimen Collection Kits Recalled Missing FDA 510(k) Clearance
BASE 10 GENETICS INC is recalling RNAstill Molecular Transport Medium Vials and specimen collection kits nationwide because they lack FDA 510(k) clearance. Approximately 455,791 kits were distributed across 18 states.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which establishes a minimum severity of 4 per the rubric. The source does not report any deaths, illnesses, or injuries, preventing a score of 5.
Plain-English summary
BASE 10 GENETICS INC is recalling RNAstill Molecular Transport Medium Vials (Catalog number MTM-001) and related specimen collection kits due to lack of FDA 510(k) clearance. The recalled kits include Catalog numbers MTM-SW03 (with oropharyngeal swab) and MTM-SW05 (with nasopharyngeal swab). Approximately 455,791 kits have been distributed.
The RNAstill Molecular Transport Medium is intended to stabilize RNA and DNA from patient specimens and allow safe transport at ambient temperature. However, the product has not received the required 510(k) regulatory clearance from the FDA.
Distribution was nationwide across 18 states: Alabama, Colorado, Florida, Georgia, Idaho, Indiana, Kentucky, Maryland, North Carolina, Nevada, New York, Ohio, Oregon, Tennessee, Utah, Virginia, Washington, and West Virginia.
Specific lot numbers affected include: For MTM-SW03—MG18401, MG18409, HH04806, KM02643, MG27906, MG28502, MG30295, and MG33903. For MTM-SW05—MG18401, MG18408, MG27901, and KC28836.
The recalled product
- 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…
- Manufacturer
- BASE 10 GENETICS INC
- Affected units
- 455,791
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Catalog #MTM-SW03: Lot numbers MG18401
- MG18409
- HH04806
- KM02643
- MG27906
- MG28502
- MG30295
- and MG33903. Catalog #MTM-SW05: Lot numbers MG18401
- MG18408
- MG27901
- and KC28836.
Distribution
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