Home › Device types › OOI
Real Time Nucleic Acid Amplification System
FDA product code OOI · Class 2 · Clinical Chemistry
406
Registered devices
2,745
Adverse events
30
Recalls
14
510(k) clearances
Devices with this code
MOCK PIE — GenePoc IncRIDA®GENE Norovirus GI/GII — R-Biopharm AGPanther Fusion® — Hologic, Inc.GeneXpert Dx System — CEPHEIDGeneXpert Dx System — CEPHEIDGeneXpert Infinity-80 System — CEPHEIDAlere i Strep A 2 — Alere Scarborough, Inc.Alinity m — ABBOTT MOLECULAR INC.Alinity m — ABBOTT MOLECULAR INC.Enteric Bacterial Panel Diluent for BD COR™ System — BECTON, DICKINSON AND COMPANYELITe InGenius® SP 200 Consumable Set — ELITECHGROUP SPAcobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems — Roche Molecular Systems, Inc.Q-Vera Prima 96 qPCR Instrument — Sansure Biotech Inc.Fluorescence Quantitative PCR Detection System — ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.BD MAX™ Enteric Parasite Panel — BECTON, DICKINSON AND COMPANYillumigene Group A Streptococcus — MERIDIAN BIOSCIENCE, INC.GeneXpert Dx System — CEPHEIDLIAISON NES® FLU A/B, RSV & COVID-19 Control Swab Kit — DIASORIN MOLECULAR LLCFluorescence Quantitative PCR Detection System — ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.Stool Bacterial Pathogens Panel — GREAT BASIN SCIENTIFIC, INC.Alinity m — ABBOTT MOLECULAR INC.BD MAX™ CPO — BECTON, DICKINSON AND COMPANYPRODESSE — Hologic, Inc.BIOER 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.