Technidata S.A. - TDHisto/Cyto - Class 2 Recall
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2023 Category: Medical Devices Source Type: alerts
Hobbs Medical, Inc. - Class 2 Recall
Hobbs Medical Cytology Brush Catalog Number: 4206 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2022 Category: Medical Devices Source Type: alerts
Hobbs Medical, Inc. - Class 2 Recall
Hobbs Medical Cytology Brush Catalog Number: 4204 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 8, 2022 Category: Medical Devices Source Type: alerts
Leica Microsystems, Inc. - HistoCare SPECTRA ST Stainer - Class 2 Recall
Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 4, 2018 Category: Medical Devices Source Type: alerts
Leica Microsystems, Inc. - Leica HistoCore SPECTRA CV Coverslipper - Class 2 Recall
Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 4, 2018 Category: Medical Devices Source Type: alerts
BioMerieux SA - Class 2 Recall
The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagn...
Source: Medical Device Recalls - June 13, 2018 Category: Medical Devices Source Type: alerts
Zeiss, Carl Inc - Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes. - Class 2 Recall
Carl Zeiss Microscopy for Laser Scanning Microscopes (Cell Observer SD, Laser TIRF and DirectFRAP Laser scanning microscopes are used in cell biology research. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 10, 2018 Category: Medical Devices Source Type: alerts
Hobbs Medical, Inc. - Hobbs Bronchial Cytology Brushes - Class 2 Recall
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2018 Category: Medical Devices Source Type: alerts
Ventana Medical Systems Inc - CINtec PLUS Cytology Kit (Canada/Japan) - Class 2 Recall
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 28, 2018 Category: Medical Devices Source Type: alerts
Ventana Medical Systems Inc - CINtec PLUS Cytology Kit (CEIVD) - Class 2 Recall
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 28, 2018 Category: Medical Devices Source Type: alerts
Richard-Allan Scientific Company - Paraffin Wax - Class 3 Recall
Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, colorless liquid when molten. The paraffin is highly quality controlled and can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. The paraffin shou...
Source: Medical Device Recalls - April 5, 2016 Category: Medical Equipment Source Type: alerts
Ge Healthcare It - GE Centricity Laboratory Software - Class 3 Recall
GE Centricity Laboratory software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use: the Centricity Laboratory is used to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
Richard-Allan Scientific Company - Mucolexx / Mucolytic Agent - Class 2 Recall
Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2015 Category: Medical Equipment Source Type: alerts
Richard-Allan Scientific Company - Lerner Laboratories Mucolexx - Class 2 Recall
Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare It - Centricity Laboratory Core Lab - Class 3 Recall
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory fac...
Source: Medical Device Recalls - January 30, 2014 Category: Medical Equipment Source Type: alerts
