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Real Time Nucleic Acid Amplification System
FDA product code OOI · Class 2 · Clinical Chemistry
413
Registered devices
2,814
Adverse events
30
Recalls
14
510(k) clearances
Devices with this code
GN 7000 Akso PCR System — Getein Biotech,IncGeneXpert Infinity-48s System — CEPHEIDFluorescence Quantitative PCR Detection System — ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.Direct Amplification Disc Kit — DIASORIN MOLECULAR LLCcobas Liat Software v3.1.1 Update Key for cobas Liat Analyzer — Roche Molecular Systems, Inc.ID NOW™ Instrument — Alere Scarborough, Inc.GeneXpert Dx System — CEPHEIDAcuitas — Opgen, Inc.Certified Pre-Owned GeneXpert Dx System — CEPHEIDFluorescence Quantitative PCR Detection System — ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.GeneXpert Dx System — CEPHEIDGeneXpert Dx System — CEPHEIDAcuitas — Curetis GmbHm2000 — ABBOTT MOLECULAR INC.GeneXpert Dx System — CEPHEIDGeneXpert Dx System — CEPHEIDTriVerity — Inflammatix, Inc.LIAISON NES® Group A Strep Control Swab Kit — DIASORIN MOLECULAR LLCAlinity m — ABBOTT MOLECULAR INC.m2000 — ABBOTT MOLECULAR INC.Rotor-Gene® Q MDx — QIAGEN GmbHMOCK PIE — Meridian Bioscience Canada IncBD Enteric Bacterial Panel for BD COR™ System — BECTON, DICKINSON AND COMPANYBIOER GeneExplorer Thermal Cycler — Hangzhou Bioer Technology Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-20 | Abbott Molecular, Inc. | The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to |
| 2024-12-10 | Biocartis Nv | False-positive MSI-H results generated by the Idylla MSI Test. |
| 2024-03-20 | Abbott Molecular, Inc. | The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system |
| 2024-02-01 | Abbott Molecular, Inc. | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. |
| 2023-12-15 | Hologic, Inc. | Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. |
| 2023-06-14 | DiaSorin Molecular LLC | There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc. |
| 2022-12-09 | Abbott Molecular, Inc. | The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their AD |
| 2022-11-11 | Abbott Molecular, Inc. | The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the in |
| 2022-10-12 | Abbott Molecular, Inc. | Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found |
| 2022-06-22 | Meridian Bioscience Inc | When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing |
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