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    APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.

    FDA Enforcement
    Class III ·Terminated·Gen-Probe Inc·June 25, 2014

    GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N 4237221, 4237212, and 4277299. Intended for use as an optional peripheral to the COULTER GEN*S System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the GEN*S System.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code KPA·May 29, 2008

    VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289) Product No: 1515808 300 slides (UDI 10758750009244) Product No: 6802198 (Japan) 90 Slides (UDI 10758750002276) All current, new and previous lots

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics, Inc.·Product code JIX·February 18, 2021

    VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code MRR·October 8, 2018

    Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·May 2, 2007

    Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code LQF·December 30, 2008

    Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·December 30, 2008

    Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code LQF·December 30, 2008

    Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,

    FDA Recall
    Terminated ·Gen Probe Inc·Product code NDZ·June 11, 2004

    APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code OIE·April 17, 2014

    VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LEG·December 11, 2018

    VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·May 21, 2012

    VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·May 21, 2012

    VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·May 21, 2012

    VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) 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 Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·September 26, 2018

    VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JIX·July 15, 2014

    VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JFY·January 29, 2014

    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·October 10, 2018

    VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289) Product No: 1515808 300 slides (UDI 10758750009244) Product No: 6802198 (Japan) 90 Slides (UDI 10758750002276) All current, new and previous lots

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics, Inc.·March 31, 2021

    AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

    FDA Recall
    Terminated ·Stryker Neurovascular·Product code DQY·May 2, 2018