Biomeme Recalls
3 recalls on record · December 9, 2020 to January 12, 2022 · Medical Devices
Recalls by year
20
21
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 12, 2022Medical DevicesFDA
Biomeme, Inc. recalls Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-S
Hazard: 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).
February 10, 2021Medical DevicesFDA
Biomeme, Inc. recalls Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis
Hazard: 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.
December 9, 2020Medical DevicesFDA
Biomeme, Inc. recalls The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nuclei
Hazard: 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.