Home › Device types › NSU
Instrumentation For Clinical Multiplex Test Systems
FDA product code NSU · Class 2 · Clinical Chemistry
199
Registered devices
139
Adverse events
13
Recalls
13
510(k) clearances
Devices with this code
BioPlex 2200 — BIO-RAD LABORATORIES, INC.cobas Buffer Negative Control Kit — Roche Diagnostics GmbHNMR Reference Standard — Labcorp of AmericaAptima® — Hologic, Inc.EUROArrayProcessor reagent tray set — EUROIMMUN Medizinische Labordiagnostika AGOpsisDx — ENTOPSIS, LLCAptima® — Hologic, Inc.Aptima Combo 2® — Hologic, Inc.Luminex® 100/200™ Calibration Kit — LUMINEX CORPORATIONINFINITI® Factor V Leiden BioFilmChip® Microarray Magazine — AUTOGENOMICS, INCSpartan RX CYP2C19 System — Spartan Bioscience IncAffymetrix — Affymetrix, Inc.FilmArray® 2.0 Instrument NGDS Configuration — BIOFIRE DEFENSE, LLCbinx io — BINX HEALTH LIMITEDBIOFIRE ® SPOTFIRE ® Control Station — BIOFIRE DIAGNOSTICS, LLCINFINITI® Factor II-V Leiden Intellipac® Reagent Module — AUTOGENOMICS, INCPanther® — Hologic, Inc.xTAG® RVP (Respiratory Viral Panel) — Luminex Molecular Diagnostics, IncAptima® — Hologic, Inc.T2Biothreat® QCheck Positive Kit — T2 BIOSYSTEMS, INC.PA500 Portrait Analyzer — GREAT BASIN SCIENTIFIC, INC.BioArray Assay Imaging SystemTM (AIS) 400C — BIOARRAY SOLUTIONS LTDLuminex® 100/200™ Performance Verification Kit — LUMINEX CORPORATIONFilmArray® Instrument — BIOFIRE DIAGNOSTICS, LLC
Recent 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 m |
| 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 swi |
| 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 ex |
| 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, expe |
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