Sysmex America, Inc. - Sysmex CF70 - Class 2 Recall
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2020 Category: Medical Devices Source Type: alerts
Beckman Coulter, Inc. - UniCel DxH Slidemaker Stainer, UniCel DxH Slidemaker Stainer II - Class 2 Recall
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 23, 2019 Category: Medical Devices Source Type: alerts
Cellavision AB - CellaVision DM96, DM1200, DM9600 and DI60 - Class 2 Recall
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 14, 2018 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - Beckman Coulter Slidemaker Stainer - Class 2 Recall
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and ...
Source: Medical Device Recalls - September 2, 2017 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System - Class 2 Recall
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 31, 2016 Category: Medical Equipment Source Type: alerts
Beckman Coulter Inc. - UniCel DxH 600 COULTER Cellular Analysis System - Class 2 Recall
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2015 Category: Medical Equipment Source Type: alerts
Dako North America Inc. - Dako Autostainer Link 48 software version 4.0.3 - Class 2 Recall
Dako Autostainer Link 48 wtih software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. The system is designed to automate manual staining methods routinely used in immunohistochemistry and cytochemistry, enabling the transfer of established protocols from the bench to the Autostainer Link 48 automated workstations operating either singly or in networked configurations. (Source...
Source: Medical Device Recalls - September 27, 2014 Category: Medical Equipment Source Type: alerts
