nCounter Digital Analyzer 5s
NANOSTRING TECHNOLOGIES, INC. · Model NCT-DIGITAL-ANALYZER-FLEX · UDI-DI 00859812006003
Description
The Digital analyzer is a part of the nCounter DX Analysis System, which consists of two instruments, the nCounter Prep Station 5s and the nCounter Digital Analyzer 5s. The Digital Analyzer is a multi-channel epifluorescence scanner configured specifically for use with NanoString’s nCounter Test Kit Cartridges.The nCounter Digital Analyzer collects data by taking images of the immobilized fluorescent reporters in the sample cartridge with a CCD camera through a microscope objective lens. Together,the NanoString nCounter DX Analysis System (liquid handling robot and epifluorescence scanner) delivers direct, multiplexed measurements of gene expression through digital readouts of the relative abundance of mRNA transcripts using the following steps: 1) a hybridization of the mRNA to fluorescent Reporter Probes and Capture Probes, 2) purification of the target/probe complexes using nCounter Prep Plates containing reagents necessary for post-hybridization processing and immobilization onto the nCounter Cartridge on the nCounter Prep Station, and 3) analysis of the nCounter Cartridge on the nCounter Digital Analyzer to provide a test result.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-22 | Nuclein LLC | Due to a software issue |
| 2025-06-25 | Nuclein LLC | Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present). |
| 2024-08-07 | BioFire Diagnostics, LLC | Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and |
| 2023-10-17 | BioFire Diagnostics, LLC | Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The ca |
| 2022-09-08 | Roche Molecular Systems, Inc. | Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses. |
| 2021-02-26 | Hologic, Inc | There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results. |
| 2020-08-04 | Hologic, Inc | Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negati |
| 2019-04-22 | Luminex Corporation | Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question. |
| 2018-01-20 | Hologic, Inc | The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator. |
| 2017-09-15 | Hologic, Inc | An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results. |
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