BEUDAMED
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    Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code JHX·April 3, 2006

    Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code JHX·November 11, 2015

    IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JHX·January 25, 2012

    IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests) --- Test code: RCK Color: Orange. For in vitro diagnostic use with the IMMULITE 2500 Analyzer --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JHX·January 25, 2012

    Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code JHX·November 11, 2015

    IMMULITE/IMMULITE Turbo 1000 CK-MB LSKCP --- Catalog number: LSKCP1 (100 tests), LSKCP5 (500 tests) --- Test code: RCK Color: Orange. For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JHX·January 25, 2012

    ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JHX·March 5, 2018

    PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

    FDA Recall
    Terminated ·Polymedco, Inc., Polymedco Cancer Diagnostic Products, Llc·Product code JHX·April 30, 2018

    Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use: Stratus(R) rotors is intended for the separation of whole blood samples for analysis on the Stratus(R) CS analyzer

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JHX·December 7, 2009

    IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 (600 tests) --- Test code: CMB Color: Dark Blue. For in vitro diagnostic use with the IMMULITE 2000 Analyzers --- for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code JHX·January 25, 2012

    Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics Inc·Product code JHX·June 22, 2016

    Stratus CS STAT Fluorometric Analyzer CKMB DilPak (CCKMB-D) in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code JHX·April 3, 2006

    Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JHX·November 26, 2003

    Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.

    FDA Recall
    Terminated ·Dade Behring, Inc.·Product code JHX·June 23, 2008

    Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable

    FDA Enforcement
    Class II ·Terminated·Jarvik Heart Inc·December 26, 2018

    AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·October 17, 2018

    Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195

    FDA Recall
    Terminated ·Kendall Healthcare Products Co·Product code MPB·December 2, 2003

    Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192

    FDA Recall
    Terminated ·Kendall Healthcare Products Co·Product code MPB·December 2, 2003

    BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5; These scales were sold for installation on or as a component of the following patient lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift; Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with Scale Patient Lift; Part Number: ERGOLIFT-2 + SC, Ergolift 400 Lbs with Scale Patient Lift; b) Manufactured for Sunrise Medical, Longmont, CO 80503: Part Number : 700.05610.06, Hoyer-600 Spreader Bar with Scale; Part Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale, Model HPL-600WBSC; Part Number: 9600132.06, Hoyer-600 Wide Opening Patient Lifter with Scale

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FRW·December 19, 2007

    Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm on label: Tyco Healthcare, Mansfield, MA. Product sold sterile, 10 units per case.

    FDA Recall
    Terminated ·Kendall Healthcare Products Co·Product code LJS·April 27, 2005