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MAGPIX®

LUMINEX CORPORATION · Model MAGPIX · UDI-DI 00840487100264

NSU Prescription

510(k) clearances

139

Adverse events

Recalls

Facilities

Description

The MAGPIX system is a multiplex test system intended to measure and sort multiple signals generated in an assay from a sample. The system includes a signal reader unit, raw data storage mechanisms, data acquisition software to process detected signals and system reagents. The MAGPIX platform is intended for use in a Clinical Diagnostic laboratory. The system will be used for protein expression and nucleic acid applications.

Recalls

Date	Firm	Reason
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.
2017-07-18	Becton Dickinson & Co.	BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some cust

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Data 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.