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    Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OHM·August 4, 2008

    Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OHM·August 4, 2008

    Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OHM·August 4, 2008

    Medline Latex Free Labor & Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OHM·August 4, 2008

    Medline Latex Free Mom/Baby Admit Kit - LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OHM·August 4, 2008

    Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.

    FDA Recall
    Terminated ·BioCheck Inc·Product code NUK·July 15, 2010

    ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LOM·August 19, 2010

    IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00630414963747 (OUS); IVD --- Made in UK Siemens Healthcare Diagnostics Products Ltd., Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with the IMMULITE Systems Analyzers for the qualitative detection of IgM antibodies to Cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the determination of an acute CMV infection.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·November 2, 2016

    SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma and serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·January 18, 2017

    Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    McKesson Cardiology Hemo

    FDA Recall
    Terminated ·Change Healthcare Israel Ltd. 26, Ha-Rokmim Holon Israel·Product code DQK·March 25, 2019

    Horizon Cardiology Hemo

    FDA Recall
    Terminated ·Change Healthcare Israel Ltd. 26, Ha-Rokmim Holon Israel·Product code DQK·March 25, 2019

    QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE module are in vitro diagnostic tests intended for the quantitative measurement of sodium, potassium, chloride and total carbon dioxide in human serum and heparinized plasma. They are also intended for the quantitative measurement of Na+, K+ and Cl- in urine.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·April 15, 2015

    Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·November 6, 2013

    Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc·July 19, 2017

    LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.

    FDA Enforcement
    Class II ·Terminated·LifeHealth, LLC·July 8, 2015