24 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
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