Recall Z-0568-2022 ยท QBD Microbial Nucleic Acid Storage And Stabilization Device
BASE 10 GENETICS INC
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
| Date | Jan 10, 2022 |
| Status | Terminated |
| Reason | The product does not have 510(k) clearance. |
| Root cause | 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 c |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.