Beckman Coulter Inc. - UniCel DxH 600 Coulter Cellular Analysis System - Class 1 Recall
UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilities. DxH 800 intended use states: The UniCel¿ DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole B...
Source: Medical Device Recalls - May 24, 2019 Category: Medical Devices Source Type: alerts
Abbott Laboratories - CELLDYN Emerald - Class 2 Recall
CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 30, 2019 Category: Medical Devices Source Type: alerts
Advanced Instruments, LLC - GloCyte Automated Cell Counter System
GloCyte Low and High Level Controls - Class 2 Recall
GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2018 Category: Medical Devices Source Type: alerts
EUROTROL INC - HemoTrol Level 2 - Class 2 Recall
HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2018 Category: Medical Devices Source Type: alerts
EUROTROL INC - HemoTrol Level 3 - Class 2 Recall
HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2018 Category: Medical Devices Source Type: alerts
Sysmex America, Inc. - Sysmex Fluorocell PLT - Class 2 Recall
Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 31, 2018 Category: Medical Devices Source Type: alerts
Roche Diagnostics Corporation - Roche cobas p 612 preanalytical system - Class 2 Recall
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that perform tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalysis, nucleic acid testing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 28, 2018 Category: Medical Devices Source Type: alerts
Roche Diagnostics Hematology - cobas m 511 integrated hematology analyzer - Class 2 Recall
cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The system prepares a stained microscope slide from EDTA anticoagulated whole blood. It utilizes computer imaging to count the formed elements of blood and provide an image-based assessment of cell morphology, which may be reviewed by the operator, and also allows for manual classification of unclassified cells. The instrument reports...
Source: Medical Device Recalls - July 27, 2018 Category: Medical Devices Source Type: alerts
BioMerieux SA - Class 2 Recall
Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 13, 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
Mindray DS USA, Inc. dba Mindray North America - M30 D Diluent - Class 2 Recall
Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-3200 and BC-3600 Hematology Analyzer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 10, 2018 Category: Medical Devices Source Type: alerts
Mindray DS USA, Inc. dba Mindray North America - M53D Diluent - Class 2 Recall
Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 10, 2018 Category: Medical Devices Source Type: alerts
Becton Dickinson & Company - Vacutainer - Class 2 Recall
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 13, 2018 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - UniCel DxH 600 Coulter Cellular Analysis System - Class 2 Recall
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities) (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 14, 2017 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - UniCel DxH Slidemaker Stainer - Class 2 Recall
UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 14, 2017 Category: Medical Devices Source Type: alerts
