Abbott Laboratories - ARCHITECT CPeptide Calibrator - Class 3 Recall
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2020 Category: Medical Devices Source Type: alerts
Clarity Diagnostics Llc - Clarity Urocheck 10SG Urinalysis Strips - Class 3 Recall
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following are...
Source: Medical Device Recalls - July 25, 2018 Category: Medical Devices Source Type: alerts
The Binding Site Group, Ltd. - Optilite Analyser - Class 2 Recall
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of...
Source: Medical Device Recalls - January 14, 2017 Category: Medical Equipment Source Type: alerts
Azer Scientific, Inc. - Glucose Tolerance Drink - Class 2 Recall
Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram ...
Source: Medical Device Recalls - November 3, 2016 Category: Medical Equipment Source Type: alerts
Azer Scientific, Inc. - Glucose Tolerance Drink - Class 2 Recall
Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads ...
Source: Medical Device Recalls - November 3, 2016 Category: Medical Equipment Source Type: alerts
Insulet Corporation - OmniPod Insulin Management System - Class 1 Recall
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2015 Category: Medical Equipment Source Type: alerts
Insulet Corporation - OmniPod Insulin Management System - Class 1 Recall
OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2015 Category: Medical Equipment Source Type: alerts
Insulet Corporation - Insulet OmniPod - Class 1 Recall
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 5, 2015 Category: Medical Equipment Source Type: alerts
Insulet Corporation - Insulet OmniPod - Class 1 Recall
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 5, 2015 Category: Medical Equipment Source Type: alerts
Medtronic MiniMed Inc. - Guardian RealTime Monitor - Class 2 Recall
Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2015 Category: Medical Equipment Source Type: alerts
Abbott Laboratories - ARCHITECT CPeptide Reagent Kit - Class 2 Recall
ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; Produced by Biokit S.A., 08186 Barcelona, Spain for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA and Abbott, 65205 Wiesbaden, Germany; list 3L53-25 The ARCHITECT C-Peptide assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System. The ARCHITECT C-Peptide assay is used as an ai...
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Siemens Healthcare Diagnostics Dimension Vista HbA1c Flex reagent cartridge and HB1C Flex reagent - Class 2 Recall
Siemens Dimension¿ HB1C Flex¿ reagent cartridge; Dimension¿ Hemoglobin A1c (HB1C) Flex¿ reagent cartridge on the Dimension¿ clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2014 Category: Medical Equipment Source Type: alerts
Roche Diagnostics Operations, Inc. - Insulin infusion pump (as part of the ACCUCHEK Aviva Combo system) - Class 2 Recall
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as pre...
Source: Medical Device Recalls - October 30, 2014 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics Inc - Siemens Healthcare CLINITEK Status Analyzer - Class 3 Recall
CLINITEK Status¿+ Analyzer (Urine chemistry analyzer) The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest¿ hCG tests. This analyzer is intended for the measurement of the following in urine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG). These measurements are used to assist diagnosis in the follow...
Source: Medical Device Recalls - May 5, 2014 Category: Medical Equipment Source Type: alerts
