BEUDAMED
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    ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.

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

    a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5% 28DAY QT (16/CS) PSS744 Catalog # 341. d. METREX RESEARCH LLC MetriCide DISINFECTANT, METRICIDE 14DAYGLUTARALDEHYDE 1GL (4/CS) Catalog # 10-1400. e. METREX RESEARCH LLC MetriCide28 DISINFECTANT, METRICIDE GLUT LNG LIFE GL (4GL/CS) Catalog # 10-2800

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code MED·May 25, 2022

    QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3

    FDA Recall
    Open, Classified ·Microgenics Corporation·Product code MLM·January 20, 2022

    IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 14, 2023

    Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica CH Analyzer Siemens Material Number (SMN): 11099440

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLX·April 5, 2023

    a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL MX-1000 METREX Catalog #13-1000. d. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE PUMP SPRAY 24OZ METREX Catalog #13-1024. e. CaviCide1 DISINFECTANT, CLNR CAVICIDE1 24OZ (12/CS) METREX Catalog #13-5024. f. METREX RESEARCH CORP DISINFECTANT, ENVIROCIDE 24OZ(12/CS) METREX Model Number: 13-3324. g. METREX RESEARCH CORP Envirocide DISINFECTANT, ENVIROCIDE GL(4/CS)MX-3300 METREX Model Number: 13-3300

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code LRJ·May 25, 2022

    Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

    FDA Recall
    Open, Classified ·Fujirebio Diagnostics, Inc.·Product code SET·December 11, 2025

    BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LIP·February 8, 2022

    Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DDZ·January 31, 2024

    Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIT·January 31, 2024

    Product Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Calibrators: The -Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G -Amyloid 1-42-N Plasma Calibrators: Liquid (Frozen), 1 1.5 mL (4 Concentrations) CAL 1 0 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 2 30 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 3 100 pg/mL -Amyloid 1-42-N Plasma Calibrator CAL 4 1000 pg/mL -Amyloid 1-42-N Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 950. Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

    FDA Recall
    Open, Classified ·Fujirebio Diagnostics, Inc.·Product code SET·December 11, 2025

    Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·November 13, 2023

    Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·July 19, 2023

    BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LIP·September 17, 2021

    Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020

    Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

    FDA Recall
    Open, Classified ·Karl Storz Endoscopy·Product code CAL·July 27, 2020