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MAGPIX® Calibration Kit
LUMINEX CORPORATION · Model MPXIVD-CAL-K25 · UDI-DI 00840487100271
NSU
Prescription
1
510(k) clearances
139
Adverse events
13
Recalls
62
Facilities
Description
The Luminex MAGPIX Calibration Kit is intended to calibrate the optics of the MAGPIX instrument. During calibration, the system adjusts LED current and calibration factors for CL1, CL2, and RP1 until those values match the imported target values, thus calibrating the classification map.
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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Get your free API keyRead the docsData 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.