BEUDAMED
    26 results · 10ms · Sources: EU EUDAMED, US FDA

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    VITROS Performance Verifier II

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics·Product code JJY·February 27, 2024

    Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control

    FDA Recall
    Open, Classified ·Microgenics Corporation·Product code JJY·October 1, 2025

    ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJY·April 24, 2025

    Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·May 4, 2023

    Multichem P, Part Code 08P90-10

    FDA Recall
    Open, Classified ·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code JJY·August 25, 2023

    Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·November 22, 2022

    Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mL

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJY·January 9, 2024

    VITROS Performance Verifier I

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics·Product code JJY·February 27, 2024

    HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJY·April 24, 2025

    Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19

    FDA Recall
    Open, Classified ·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code JJY·August 25, 2023

    OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)

    FDA Recall
    Open, Classified ·POLYMEDCO, INC. POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC·Product code JJY·October 6, 2025

    Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·November 22, 2022

    Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·February 18, 2020

    VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

    FDA Recall
    Open, Classified ·Ortho Clinical Diagnostics Inc·Product code JJY·October 16, 2020

    Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·June 21, 2023

    Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·May 4, 2023

    Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·August 3, 2023

    Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·November 22, 2022

    Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

    FDA Recall
    Open, Classified ·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code JJY·August 25, 2023

    Abbott Point of Care Control Control i-STAT Level 3 1.7 mL

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JJY·January 9, 2024