Becton Dickinson & Co. - BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station - Class 3 Recall
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 6, 2018 Category: Medical Devices Source Type: alerts
Biocare Medical, LLC - URO3 Triple Stain (CD44 p52 CK20) - Class 2 Recall
URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with CK20 is a cocktail of mouse monoclonal and rabbit monoclonal antibodies that is intended for laboratory use in the qualitative identification of CD44, p53 and CK20 proteins by immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues, primarily for bladder cancer characterization. The clinical interpretation of any staining o...
Source: Medical Device Recalls - September 20, 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
Leica Microsystems, Inc. - LEICA BIOSYSTEMS NEWCASTLE LTD - Class 2 Recall
Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2016 Category: Medical Equipment Source Type: alerts
Cimzia (certolizumab pegol) for Injection, for Subcutaneous Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
WARNINGS AND PRECAUTIONS
5.2 Malignancies
Melanoma and Merkel cell carcinoma have been reported in patients treated... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Lab Vision Corporation - CD66e, Ab2 (CEA antibody) - Class 3 Recall
CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be vie...
Source: Medical Device Recalls - February 18, 2016 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi - Class 3 Recall
IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 14, 2014 Category: Medical Equipment Source Type: alerts
