Biomeme, Inc.
Country not established
- Devices
- 13
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Search and filter all 13 devicesCompany details
- DUNS number
- 079110357
- [email protected]
- Phone
- 2679307707
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 1
- 2021 2
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 20 Oct 2021 Z-0452-2022 Class II Terminated The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when
stored at room temperature. Ongoing stability studies have indicated the need to shorten the life
of the RPC Buffer once resuspended from the current instruction of one week to two days
when stored at room temperature (15degC-30degC).
Full distribution text
- 5 Jan 2021 Z-0940-2021 Class III Terminated Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.
- 20 Oct 2021 Z-0452-2022 Class II Terminated The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when
stored at room temperature. Ongoing stability studies have indicated the need to shorten the life
of the RPC Buffer once resuspended from the current instruction of one week to two days
when stored at room temperature (15degC-30degC).
2020
- 23 Oct 2020 Z-0513-2021 Class II Terminated The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.
Full distribution text
- 23 Oct 2020 Z-0513-2021 Class II Terminated The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.
Frequently asked questions
How many devices does Biomeme, Inc. have in the registry?
The registry currently lists 13 devices for Biomeme, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biomeme, Inc.'s devices?
Among its 13 most recently registered devices, Biomeme, Inc. has devices listed in FDA GUDID (13 devices).
Are there FDA recall records for Biomeme, Inc.?
FDA recall records list 3 recalls initiated by Biomeme, Inc., the most recent initiated on 2021-10-20. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Biomeme, Inc. in the registry?
The most recently registered devices listed for Biomeme, Inc. include Biomeme SARS-CoV-2 Go-Strips Kit 1, Biomeme Franklin three9 Real-Time PCR Thermocycler 2.8, Biomeme RNA Process Control (RPC) Kiit 1 and Biomeme SARS-CoV-2 Go-Plates Kit 1.