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    Dimension Assays: Uric Acid (URCA)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KNK·March 17, 2016

    Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·April 13, 2016

    Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KNK·March 17, 2016

    ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method).

    FDA Recall
    Terminated ·Horiba Instruments Inc·Product code KNK·January 11, 2016

    Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code KNK·December 1, 2009

    Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·December 15, 2014

    VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KNK·August 11, 2016

    Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·August 24, 2018

    Dimension Vista Assays: Uric Acid (URCA)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code KNK·March 17, 2016

    Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the quantitative determination of uric acid concentration in human serum, plasma or urine.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·April 3, 2017

    VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric acid (URIC) concentration in serum, plasma, and urine 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 KNK·June 12, 2013

    Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code KNK·August 15, 2019

    Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code KNK·May 7, 2015

    Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code KNK·December 1, 2009

    Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238.

    FDA Recall
    Terminated ·Steritec Products Mfc. Co., Inc.·Product code JOJ·July 15, 2009

    Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; 6260-3-016 T3 MOD REV DIST STM 16MMX225MM; 6260-3-017 T3 MOD REV DIST STM 17MMX225MM; 6260-3-018 T3 MOD REV DIST STM 18MMX225MM; 6260-3-019 T3 MOD REV DIST STM 19MMX225MM; 6260-3-020 T3 MOD REV DIST STM 20MMX225MM; 6260-3-022 T3 MOD REV DIST STM 22MMX225MM; 6230-3-024 T3 MOD REV DIST STM 24MMX225MM; 6260-3-114 T3 MOD REV DIST STM 14MMX265MM; 6260-3-115 T3 MOD REV DIST STM 15MMX265MM; 6260-3-116 T3 MOD REV DIST STM 16MMX265MM; 6260-3-117 T3 MOD REV DIST STM 17MMX265MM; 6260-3-118 T3 MOD REV DIST STM 18MMX265MM; 6260-3-119 T3 MOD REV DIST STM 19MMX265MM; 6260-3-120 T3 MOD REV DIST STM 20MMX265MM; 6260-3-122 T3 MOD REV DIST STM 22MMX265MM; 6260-3-124 T3 MOD REV DIST STM 24MMX265MM; 6260-3-214 KINKED T3 DIST STM 14MMX265MM; 6260-3-215 KINKED T3 DIST STM 15MMX265MM; 6260-3-216 KINKED T3 DIST STM 16MMX265MM; 6260-3-217 KINKED T3 DIST STM 17MMX265MM; 6260-3-218 KINKED T3 DIST STM 18MMX265MM; 6260-3-219 KINKED T3 DIST STM 19MMX265MM; 6260-3-220 KINKED T3 DIST STM 20MMX265MM; 6260-3-222 KINKED T3 DIST STM 22MMX265MM; 6260-3-224 KINKED T3 DIST STM 24MMX265MM; 6260-3-314 KINKED T3 DIST STM 14MMX305MM; 6260-3-315 KINKED T3 DIST STM 15MMX305MM; 6260-3-316 KINKED T3 DIST STM 16MMX305MM; 6260-3-317 KINKED T3 DIST STM 17MMX305MM; 6260-3-318 KINKED T3 DIST STM 18MMX305MM; 6260-3-319 KINKED T3 DIST STM 19MMX305MM; 6260-3-320 KINKED T3 DIST STM 20MMX305MM; 6260-3-322 KINKED T3 DIST STM 22MMX305MM; 6260-3-324 KINKED T3 DIST STM 24MMX305MM; LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE; 6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY; LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES; LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics·Product code LZO·December 30, 2003

    Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·August 12, 2015

    Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

    FDA Enforcement
    Class II ·Terminated·Insulet Corporation·March 17, 2021

    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

    FDA Recall
    Terminated ·Viscot Medical LLC·Product code FZZ·August 22, 2012

    Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code NDG·August 28, 2013