Alethia™ Mycoplasma Direct
MERIDIAN BIOSCIENCE, INC. · Model 480250 · UDI-DI 00840733102189
Description
The Alethia Mycoplasma Direct DNA amplification assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The Alethia Mycoplasma Direct assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the Alethia Mycoplasma Direct DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management. Positive results do not rule out co-infection with other organisms and negative results in persons with respiratory tract infections may be due to pathogens not detected by this assay. Lower respiratory tract infections due to M. pneumoniae may not be detected by this assay. If lower respiratory tract infection due to M. pneumoniae is suspected, additional laboratory testing using methods other than the Alethia Mycoplasma Direct DNA Amplification Assay may be necessary.
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 flow beyond the foot |
| 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 will generate the me |
| 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 ADUs serviced may have |
| 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 instrument was returne |
| 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 to not open when th |
| 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 the user to heated |
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