LetsGetChecked Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3020139194
- Devices
- 0
- Registrations
- FDA
- FDA recalls
- 11 ongoing
Company details
- FDA FEI number
- 3020139194
- Address
- 10825 7th Street, Suite A, Cucamonga, CA, 91730
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 16 Mar 2022 Z-1212-2023 Class II Ongoing Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned to another user resulting in a mismatch of user identification. The impact to users is that they may return the sample and obtain potential incorrect Hepatitis C Virus (HCV) results and/or the sample may be rejected due to mismatched demographics resulting in delayed testing and/or treatment.