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Biomeme, Inc. FDA Recalls
2 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-SClass IIOct 20, 2021The current IFU specifies a shelf-life of one week after res |
| Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis Class IIIJan 5, 2021Users cannot complete testing due to a sign-error in the sof |