Siemens Healthcare Diagnostics, Inc. - ADVIA Chemistry Hemoglobin A1c_3 Reagent - Class 2 Recall
ADVIA Chemistry Hemoglobin A1c_3 Reagent. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 26, 2015 Category: Medical Equipment Source Type: alerts
TZ Medical Inc. - SilverStat, 887007 - Class 2 Recall
SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870 -07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 20, 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
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
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
VITA-RX DIABETIC VITAMIN (Vitamin C, Vitamin D, Vitamin E, Thiamine, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Biotin, Pantothenic Acid, Chromium) Capsule, Gelatin Coated [Pure Source, Inc.]
Updated Date: Aug 13, 2015 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - August 13, 2015 Category: Drugs & Pharmacology Source Type: alerts
VITA-RX DIABETIC VITAMIN (Vitamin C, Vitamin D, Vitamin E, Thiamine, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Biotin, Pantothenic Acid, Chromium) Capsule, Gelatin Coated [MAS Management Group Inc.]
Updated Date: Aug 12, 2015 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - August 12, 2015 Category: Drugs & Pharmacology 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
Metrika Inc - A1CNOW - Class 2 Recall
A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA 94085. (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used by professional healthcare providers to monitor long-term glycemic control in people with diabetes. The product is sold as a kit with a disposable monitor and reagents for ten A1C tests and is suitable for use at the point-of-care. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2015 Category: Medical Equipment Source Type: alerts
Roche Diabetes Care, Inc. - Roche AccuCheck Spirit - Class 2 Recall
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 10, 2015 Category: Medical Equipment Source Type: alerts
Roche Diabetes Care, Inc. - Roche AccuCheck Spirit - Class 2 Recall
AccuChek Spirit insulin infusion pump. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 10, 2015 Category: Medical Equipment Source Type: alerts
CORTIZONE 10 ANTI-ITCH FOR DIABETICS SKIN (Hydrocortisone) Lotion [Chattem, Inc.]
Updated Date: Apr 6, 2015 EST (Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST))
Source: DailyMed Drug Label Updates for the last seven days (since May 20, 2007 EST) - April 6, 2015 Category: Drugs & Pharmacology Source Type: alerts
Roche Diabetes Care, Inc. - ACCUCHEK Connect Diabetes Management App - Class 2 Recall
ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 3, 2015 Category: Medical Equipment Source Type: alerts
Medtronic MiniMed Inc. - Medtronic MiniMed CareLink Pro 4.0 and Clinical - Class 3 Recall
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump models - read device data from the CareLink Online system - write new device data to the CareLink system - generate reports from th...
Source: Medical Device Recalls - March 3, 2015 Category: Medical Equipment Source Type: alerts
