BEUDAMED
    730 results · 68ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MLM·June 15, 2010

    Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·August 31, 2011

    The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MMI·April 12, 2010

    The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CEC·April 12, 2010

    The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·April 12, 2010

    MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LRG·June 2, 2014

    Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.

    FDA Recall
    Terminated ·Siemens Medical Solutions Diagnostics·Product code DGC·January 5, 2009

    Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·May 5, 2010

    Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code MYF·February 8, 2021

    Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used for calibration of the cardiac troponin I method on the Stratus CS analyzer.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MMI·April 28, 2008

    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LTT·March 6, 2013

    Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk of stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MMI·April 8, 2008

    MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog Nos. B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101

    FDA Recall
    Terminated ·Siemens Microscan·Product code JWY·July 31, 2008

    Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDD·May 8, 2012

    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JGS·July 7, 2025

    Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LCD·November 30, 2010

    MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels, 20 panels per box. Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog numbers B1016-100, B1016-101, B1016-102, B1016-105, B1016-107, B1016-108, B1016-109, B1016-119, B1016-120, B1016-121, B1016-122, B1016-126, B1016-127, B1016-128, B1016-129, B1016-131, B1016-132, B1016-61a, B1016-62a, B1016-64a, B1016-65a, B1016-80, B1016-82, B1017-300, B1017-301, B1017-302, B1017-303, B1017-304, B1017-305, B1017-306, B1017-307, B1017-308, B1017-309, B1017-312, B1017-313, B1017-315, B1017-400, B1017-401, B1017-402, B1017-403, B1017-404, B1017-405, B1017-406, B1017-407, J1016-311c, J1016-312c, J1016-611c, J1016-611j, J1016-612b, J1016-612J, J1016-632J, J1016-623m, J1016-631J, J1016-632J, J1016-65c, J1016-66J, J1025-311, J1025-312, J1025-333, and J1025-611

    FDA Recall
    Terminated ·Siemens Microscan·Product code LON·July 31, 2008

    Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JHM·February 3, 2021

    Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIX·August 31, 2009

    Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·August 15, 2019