Chicago, IL, United States
BASE 10 GENETICS INC recalls
1 recall recorded since 2018, most recently on 10 January 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 10 January 2022
- Terminated
- 27 September 2024
- Reason
- The product does not have 510(k) clearance.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0568-2022
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.