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    Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer.

    FDA Recall
    Terminated ·Cholestech Corp·Product code DCK·August 9, 2006

    The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code DCK·March 6, 2013

    TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DCK·December 5, 2003

    "K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic use.

    FDA Recall
    Terminated ·Kamiya Biomedical Company, LLC·Product code DCK·May 1, 2009

    VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DCK·October 26, 2016

    VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma 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 DCK·June 12, 2013

    Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DCK·November 22, 2004

    Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only

    FDA Recall
    Terminated ·Medtest Holdings, Inc.·Product code DCK·July 21, 2009

    K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP(2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The other vial labeled K-ASSAY CRP(2) R-2 20 mL Latex Suspension human CRP rabbit antibodies, vial has a red cap.

    FDA Recall
    Terminated ·Kamiya Biomedical Company·Product code DCK·April 11, 2006

    POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum.

    FDA Recall
    Terminated ·Polymedco, Inc·Product code DCK·December 3, 2003

    IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280. Intended for the quantitative determination of C-Reactive Protein (CRP) in human serum or plasma by rate nephelometry.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DCK·January 10, 2008

    VITROS CRP Slides: (1) Cat # 192 6740, 250 slides per box, and (2) Cat # 809 7990, 90 slides per box. Firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626. The CRP Slides are for use on the Vitros 250/250AT and/or Vitros 950/950AT Clinical Chemistry Systems. For in vitro diagnostic use. Vitros CRP slides quantitatively measure C-reactive protein concentration in serum and plasma.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DCK·July 28, 2004

    POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum

    FDA Recall
    Terminated ·Polymedco, Inc·Product code DCK·December 3, 2003

    VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma 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 DCK·May 9, 2013

    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 Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 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 Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 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

    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

    Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their kinase activity thereby stopping cell cycle progression. It also binds to PCNA (proliferating cell nuclear antigen) and blocks DNA replication but not the DNA repair process. Product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.

    FDA Enforcement
    Class III ·Terminated·Lab Vision Corporation·December 2, 2015

    EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to coagulate cardiac tissue. The flexible, cooled electrode device, with a suction stabilizer feature, transmits radiofrequency (RF) energy from an Electrosurgical Generator (non-sterile, re-useable) connected through an Instrument Cable (sterile). A temporary sensing electrode feature may be used with an off-the-shelf electrogram recording system with the use of an additional instrument cable (non-sterile). An accessory Cannula may be used to facilitate coagulation device access and visibility of the heart. The EPi-Sense Guided Coagulation System with VisiTrax technology is intended for the coagulation of cardiac tissue using Radiofrequency (RF) energy using thoracoscopic, endoscopic, and laparoscopic surgical techniques and may be used for temporary cardiac signal sensing and recording during surgery when connected to a temporary external recording device.

    FDA Enforcement
    Class II ·Terminated·AtriCure, Inc.·July 3, 2019