Recall Z-0568-2022— BASE 10 GENETICS INC
Class I · Terminated
Class I FDA medical device recall by BASE 10 GENETICS INC, initiated 2022-01-10, terminated 2024-09-27. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The product does not have 510(k) clearance..
- Recalling firm
- BASE 10 GENETICS INC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2022-01-10
- Terminated
- 2024-09-27
- Firm location
- Chicago, IL, United States
Product description
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.
Reason for recall
The product does not have 510(k) clearance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.