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    ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024

    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024

    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·August 11, 2025

    Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021

    VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code CEK·December 15, 2020

    Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·January 27, 2023

    Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CEK·March 26, 2003

    VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CEK·June 12, 2013

    VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code CEK·December 15, 2020

    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021

    Natural-Knee II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ00/0-R

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB INSER SZ2-13MM AK CCK TIB INSER SZ2-16MM AK CCK TIB INSER SZ2-22MM AK CCK TIB INSER SZ2-30MM AK CCK TIB INSER SZ3-16MM AK CCK TIB INSER SZ3-22MM AK CCK TIB INSER SZ3-25MM AK CCK TIB INSER SZ4-13MM AK CCK TIB INSER SZ4-16MM AK CCK TIB INSER SZ5-11MM AK CCK TIB INSER

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.

    FDA Recall
    Open, Classified ·Ge Healthcare·Product code RCC·May 8, 2020

    Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DHX·October 13, 2015

    CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.

    FDA Recall
    Terminated ·Lab Vision Corporation·Product code NJT·January 18, 2016

    IMMULITE /IMMULITE 1000 CEA

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DHX·January 2, 2018

    IMMULITE 2000/IMMULITE 2000 XPi CEA

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DHX·January 2, 2018

    Immulite 1000 CEA Catalog No. LKCE1

    FDA Recall
    Terminated ·Diagnostic Products Corp·Product code DHX·May 3, 2004

    Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DHX·April 12, 2006

    ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker

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