Allergy & Immunology Alerts
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Roche Molecular Systems, Inc. - Instrument Manager - Class 2 Recall
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 7, 2012 Category: Medical Equipment Source Type: alerts
Immunodiagnostics Systems Ltd - IDS Urine BETA CrossLaps ELISA - Class 2 Recall
IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps¿ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapi...
Source: Medical Device Recalls - October 10, 2012 Category: Medical Equipment Source Type: alerts
Phadia US Inc - PHADIA VarelisA Cardiolipin IgM Antibodies Assay - Class 3 Recall
PHADIA VarelisA Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 28, 2012 Category: Medical Equipment Source Type: alerts
Beckman Coulter Inc. - SYNCHRON Rheumatoid Factor (RF) Reagent - Class 2 Recall
SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 8, 2012 Category: Medical Equipment Source Type: alerts
Nurse Assist, Inc - McKesson MediPak - Class 2 Recall
McKESSON Medi-Pak Urethral Catheter Tray with Red Rubber Catheter Sterile.Single Use.Disposable 20 Trays Per Case Reorder No. 37-232 CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Urethral Catheter Tray with Red Rubber Catheter (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2012 Category: Medical Equipment Source Type: alerts
Bio-Rad Laboratories - Rubella IgG EIA test kit - Class 3 Recall
Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052 For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - March 16, 2010 Category: Medical Equipment Source Type: alerts
Diamedix Corporation - Is-Measles IgG Enzyme Immunoassay Test Kit - Class 2 Recall
Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - January 7, 2009 Category: Medical Equipment Source Type: alerts
FDA Okays Nasal Spray for Allergy-Caused Sniffles in Pre-Schoolers
BRIDGEWATER, N.J. (MedPage Today) -- The FDA has approved triamcinolone acetonide nasal spray (Nasacort AQ) for sneezing, runny nose, and congestion caused by allergic rhinitis in children ages two to five, according to the drug maker. (Source: MedPage Today Product Alert)
Source: MedPage Today Product Alert - September 23, 2008 Category: Drugs & Pharmacology Source Type: alerts
FDA Increases Death Count Associated with Tainted Heparin to 62
ROCKVILLE, Md. -- The FDA said today there have been 62 fatal allergic reactions following the use of apparently adulterated heparin, and 56 of the deaths were reported since the agency drew attention to the problem at the first of the year. (Source: MedPage Today Product Alert)
Source: MedPage Today Product Alert - April 8, 2008 Category: Drugs & Pharmacology Source Type: alerts
Chemically Altered Chondroitin-Sulfate Found in Recalled Heparin
ROCKVILLE, Md. -- The FDA said today that hypersulfated chondroitin sulfate is the contaminant in heparin that has been linked to serious allergic reactions and at least 19 deaths. (Source: MedPage Today Product Alert)
Source: MedPage Today Product Alert - March 19, 2008 Category: Drugs & Pharmacology Source Type: alerts
Chemically Alerted Chondroitin-Sulfate Found in Recalled Heparin
ROCKVILLE, Md. -- The FDA said today that over-sulfated chondroitin sulfate is the contaminant in heparin that has been linked to serious allergic reactions and at least 19 deaths. (Source: MedPage Today Product Alert)
Source: MedPage Today Product Alert - March 19, 2008 Category: Drugs & Pharmacology Source Type: alerts
September 21, 2007: Immunizations Are Discontinued in Two HIV Vaccine Trials
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced on September 21, 2007, that based on a review of interim data, all sites in the STEP study ceased administering the investigational vaccine. (Source: Clinical Alerts and Advisories)
Source: Clinical Alerts and Advisories - September 24, 2007 Category: Research Source Type: alerts
FDA and CDC Help Sleuth Deaths in Panama
ROCKVILLE, Md. -- The deaths of 21 people in Panama, at first associated with generic lisinopril, appear to have been caused by government-made cough and anti-allergy syrups deliberately contaminated with diethylene glycol. (Source: MedPage Today Product Alert)
Source: MedPage Today Product Alert - October 12, 2006 Category: Drugs & Pharmacology Source Type: alerts
Becton Dickinson & Company - SafetyGlide - Class 2 Recall
BD 1mL SafetyGlide Allergy and Tuberculin Syringes. Reorder Number 305945 and 305950. (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - October 4, 2006 Category: Medical Equipment Source Type: alerts
January 18, 2006: International HIV/AIDS Trial Finds Continuous Antiretroviral Therapy Superior to Episodic Therapy
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced on January 18, 2006, that enrollment into a large international HIV/AIDS trial comparing continuous antiretroviral therapy with episodic drug treatment guided by levels of CD4+ cells has been stopped. Enrollment was stopped because those patients receiving episodic therapy had twice the risk of disease progression (the development of clinical AIDS or death), the major outcome of the study. (Source: Clinical Alerts and Advisories)
Source: Clinical Alerts and Advisories - September 21, 2006 Category: Research Source Type: alerts
Thera Test Laboratories, Inc. - EL-aCL Anti-Cardiolipin ELISA Kit - Class 3 Recall
EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148 (Source: Medical Device Recalls since July 07, 2006)
Source: Medical Device Recalls since July 07, 2006 - May 20, 2006 Category: Medical Equipment Source Type: alerts

