BEUDAMED
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    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patients age, previous biopsy, and digital rectal exam (DRE). Patients file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculation when values of the four analytes are available. The 4Kscore test results are determined automatically by the validated laboratory information system algorithm calculation software.

    FDA Recall
    Open, Classified ·BioReference Health, LLC·Product code QRF·November 18, 2022

    The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patient s age, previous biopsy, and digital rectal exam (DRE).

    FDA Recall
    Open, Classified ·BioReference Health, LLC·Product code QRF·October 31, 2023

    PSA Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code LTJ·November 3, 2025

    IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code MTF·September 30, 2024

    ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.

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

    Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16

    FDA Recall
    Open, Classified ·Cell Marque Corporation·Product code NJT·July 15, 2021

    Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450

    FDA Recall
    Open, Classified ·Davol, Inc.·Product code FTL·April 25, 2023

    CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT)

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NKE·April 6, 2021

    Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No

    FDA Recall
    Open, Classified ·Medistim Asa Okernveien·Product code DPW·September 26, 2025

    FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Recall
    Open, Classified ·Hill-Rom, Inc.·Product code FSA·August 11, 2021

    Sit to Stand STS500 Patient Lift

    FDA Recall
    Open, Classified ·Med-Mizer, Inc.·Product code FSA·February 3, 2023

    Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment

    FDA Recall
    Open, Classified ·Arjohuntleigh Magog, Inc.·Product code FSA·February 17, 2023

    LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Recall
    Open, Classified ·Hill-Rom, Inc.·Product code FSA·August 11, 2021

    Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015

    FDA Recall
    Open, Classified ·Hill-Rom, Inc.·Product code FSA·December 23, 2021

    MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems

    FDA Recall
    Open, Classified ·Volcano Corp·Product code DSA·February 3, 2022

    Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table

    FDA Recall
    Open, Classified ·Pivotal Health Solutions, Inc.·Product code ISA·October 9, 2025

    Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FSA·February 21, 2022

    Hanger-Bar 2P 45cm

    FDA Recall
    Open, Classified ·Human Care USA, Inc.·Product code FSA·November 1, 2021

    Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021

    FDA Recall
    Open, Classified ·Moller Vital Hadelandsvegen 2·Product code FSA·February 4, 2019

    Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds.

    FDA Recall
    Open, Classified ·Community Products, LLC·Product code FSA·December 18, 2025