32 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code IDZ·April 4, 2013
Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 Material:701049440R01
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular, LLC·June 5, 2019
Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 1-PATIENT HOSE 22mmIDx6'' 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 48'' w/CUFF 1/4''ID 1-ADULT PRESSURE TEE w/CUFF 1-EXHALATION VALVE LINE 1/8''IDx48'' 2-ADAPTERS 22mmx22mm
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code CBK·December 6, 2004
Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-7 Labeled in part: ONE SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-EXHALATION VALVE LINE 1/8''IDx90'' 1-PATIENT HOSE 22mmIDx18'' 1-PATIENT HOSE 22mmIDx6'' 1-PRESSURE GAGE LINE 84'' w/CUFF 1/4''ID 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code CBK·December 6, 2004
Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-9 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A-9 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-EXHALATION VALVE LINE 1/8''IDx108'' 1-PATIENT HOSE 22mmIDx36'' 1-PATIENT HOSE 22mmIDx6'' 1-PRESSURE GAGE LINE 1-EXHALATION VALVE w/HOLDING ARM&COLLECTION HEAD 102'' w/CUFF 1/4''ID 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code CBK·December 6, 2004
The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal and dissection of tissue in arthroscopic surgeries. A generator or controller serves as the power unit. Soft tissue ablators are available in a wide range of sizes and angles; some models include thermal or suction functions. The outer box of the Reprocessed Mitek Arthroscopic Wand is labeled in part: "***ASCENT HEALTHCARE SOLUTIONS Lakeland, FL***Contents sterile by EO unless package is opened or damaged.***Reprocessed Device for single use. Reprocessed By Ascent Healthcare Solutions.***Cat #: 225301 MITEK 3.5mm SIDE EFFECT ELECTRODE***Lot #: 674290 Expiration Date: 04/2012***" Individual pouch labeled in part: "***Cat #: 225301***MITEK 3.5mm SIDE EFFECT ELECTRODE****IFU at www.ascenths.com***Contents: One Expiration Date 04/2012***Lot # 674201 ID# 0***Reprocessed by Ascent Healthcare Solutions Not affiliated with the original manufacturer.***ASCENT HEALTHCARE SOLUTIONS Lakeland, FL***"
FDA Recall
Terminated
·Stryker Sustainability Solutions, Inc.·Product code GEI·June 1, 2009
25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in adult populations.
FDA Enforcement
Class II
·Terminated·IDS (Immunodiagnostic Systems Ltd.)·January 23, 2013
Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code CDZ·March 21, 2018
IMMULITE 2000 Total Testosterone Kit
FDA Recall
Terminated
·Diagnostic Products Corp.·Product code CDZ·January 3, 2006
ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CDZ·March 5, 2018
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CDZ·November 30, 2018
Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617 The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CDZ·July 26, 2010
ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code CDZ·March 5, 2018
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.
FDA Recall
Terminated
·Abbott Laboratories·Product code CDZ·April 18, 2017
VIDAS Testosterone, Ref 30418
FDA Recall
Terminated
·bioMerieux, Inc.·Product code CDZ·May 15, 2017
DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
FDA Recall
Terminated
·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code CDZ·May 21, 2019
Device to determine quantitative total testosterone in human serum
FDA Recall
Terminated
·Qualigen Inc·Product code CDZ·September 19, 2003
The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
FDA Recall
Terminated
·Qualigen Inc·Product code CDZ·November 6, 2019
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.
FDA Recall
Terminated
·Qualigen Inc·Product code CDZ·November 8, 2013