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EUROArrayProcessor reagent tray set
EUROIMMUN Medizinische Labordiagnostika AG · Model ZM 9999-0640-5 · UDI-DI 04049016148265
10
510(k) clearances
139
Adverse events
13
Recalls
62
Facilities
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.