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    Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit contains 6 x 90 tests, HDL Buffer (R1) and HDL Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.

    FDA Recall
    Terminated ·Stanbio Laboratory, Inc·Product code LBR·September 18, 2006

    Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·November 10, 2009

    Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240, and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·January 29, 2009

    Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; . (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·November 10, 2009

    Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·January 29, 2009

    Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.

    FDA Recall
    Terminated ·Stanbio Laboratory, Inc·Product code LBR·September 18, 2006

    Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Medtest Holdings, Inc.·Product code LBR·August 10, 2018

    Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HDL-Cholesterol Buffer (R1) and 2/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.

    FDA Recall
    Terminated ·Stanbio Laboratory, Inc·Product code LBR·September 18, 2006

    LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.

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

    Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code LBR·March 13, 2015

    Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code LBR·July 20, 2016

    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code QAN·November 19, 2021

    Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011

    FDA Recall
    Terminated ·Clinical Diagnostic Solutions, Inc.·Product code GKZ·January 2, 2020

    Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011

    FDA Enforcement
    Class II ·Terminated·Clinical Diagnostic Solutions, Inc.·February 12, 2020

    Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·January 12, 2022

    Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code QAN·March 16, 2021

    Smith & Nephew Endoscopic Disposable Blades: NOTCHBLASTER ABR,EP-1,5.5 DSPL Part #: 7205329. DYONICS Series 3000 BONECUTTER Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty.

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code NBH·May 7, 2009

    Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc.·May 12, 2021