24 results · 27ms · Sources: EU EUDAMED, US FDA

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HORIBA custom configured fluorescence instrument, modular Fluorolog-QM

FDA Recall
Open, Classified ·Horiba Instruments Incorporated·Product code REM·March 28, 2024

Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER-ILC.

FDA Recall
Open, Classified ·WASATCH PHOTONICS·Product code REM·August 4, 2025

EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU

FDA Recall
Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU

FDA Recall
Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

FDA Recall
Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

Mito Red Light, Super Mobile

FDA Recall
Open, Classified ·MITO RED LIGHT INC·Product code ILY·February 12, 2025

Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023

FlexLab (FLX); Version: FLX-217-10;

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·October 30, 2025

FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·September 3, 2025

Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions: FLX-247-00 Firmware versions: COBASa_2.2.0, COBASa_2.3.0

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·November 3, 2023

Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023

FlexLab (FLX); Version: FLX-217-40;

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·October 30, 2025

PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023

Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·April 7, 2020

Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023

Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023

RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

FDA Recall
Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code CEM·September 6, 2023

FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·September 3, 2025

Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·April 7, 2020

Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

FDA Recall
Open, Classified ·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code CEM·April 14, 2021