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Biomeme GoDx App for US
Biomeme, Inc. · Model 2.3.5 · UDI-DI 00810096640130
0
510(k) clearances
20,139
Adverse events (8 deaths)
40
Recalls
55
Facilities
Description
App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-28 | Abbott Molecular, Inc. | There were reports of an increase in reactive negative controls and false positive results. |
| 2025-04-28 | Abbott Molecular, Inc. | There were reports of an increase in reactive negative controls and false positive results. |
| 2024-05-07 | Becton Dickinson & Co. | Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing. |
| 2023-05-15 | NeuMoDx Molecular Inc | Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SAR |
| 2023-05-09 | Qiagen GmbH | If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortio |
| 2023-01-30 | DiaSorin Molecular LLC | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes. |
| 2022-12-15 | Meridian Bioscience Inc | Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2 |
| 2022-11-22 | Abbott Molecular, Inc. | Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits. |
| 2022-11-22 | Abbott Molecular, Inc. | Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits. |
| 2022-09-14 | Luminex Corporation | A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.