BIO-RAD LABORATORIES INC

EVOLIS · Hematology

510(k): 0 Recall: 2 UDI: 0 MAUDE: 6 Class.: 56

Recalls (2)

EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.

2019-01-10

User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS).

EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.

2015-12-22

The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter.

MAUDE Adverse Events (6)

Other

20130724

Other

20110823

Other

20100803

Other

20100527

Malfunction

20090821

Malfunction

20081101

FDA Classification (56)

Assay, Heparin

Hematology

Adamts13 Activity Test System

Hematology

Stain, Papanicolau

Hematology

Tablet, Resazurin

Hematology

Solution, Silver Carbonate

Hematology

Ethyl Eosin

Hematology

Lymphocyte Separation Medium

Hematology

Microscope, Automated, Image Analysis, Operator Intervention

Hematology

Test, Sickle Cell

Hematology

Nigrosin

Hematology

Control, Platelet

Hematology

Oxyhemoglobin

Hematology

Plasma, Coagulation Control

Hematology

Indigocarmine

Hematology

Antithrombin Iii Quantitation

Hematology

Dna-Probe, B And T Lymphocyte

Hematology

Stains, Chemical Solution

Hematology

Neutral Red

Hematology

Reagent, Schiff

Hematology

Reagent, Russel Viper Venom

Hematology

Romanowsky Stains

Hematology

Centrifuge, Microsedimentation

Hematology

Giemsa Stain

Hematology

Adenine Nucleotide Quantitation

Hematology

Stains, Microbiologic

Hematology

Separator, Automated, Blood Cell, Diagnostic

Hematology

Centrifuge, Cell-Washing, Automated For Immuno-Hematology

Hematology

Analyzer, Chromosome, Automated

Hematology

Immunohistochemistry Reagents And Kits

Hematology

Products, Red-Cell Lysing Products

Hematology

Carbol Fuchsin

Hematology

Counter, Differential Cell

Hematology

Control Material, Blood Circulating Epithelial Cancer Cell

Hematology

Hemoglobinometer

Hematology

Crystal Violet For Histology

Hematology

Warmer, Blood, Non-Electromagnetic Radiation

Hematology

System, Automated Platelet Aggregation

Hematology

Whole Blood Hemoglobin Determination

Hematology

Jenner Stain

Hematology

Red-Cell Count By Photometry

Hematology

Stains, Heinz Body

Hematology

Fluid, Diluting, Red-Cell

Hematology

Reagent, Thromboplastin And Control

Hematology

Hematoxylin, Chrome Alum

Hematology

Reagent & Control, Partial Thromboplastin Time

Hematology

Hemoglobin For Donor Testing

Hematology

Carmine

Hematology

Bothrops Atrox Reagent

Hematology

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

Hematology

Auramine O

Hematology

Assay, Glycosylated Hemoglobin

Hematology

Mucicarmine

Hematology

Control, Hemoglobin

Hematology

Red-Cell Indices, Measured

Hematology

Blood Establishment Computer Software And Accessories

Hematology

Van Gieson'S Picro-Fuchsin

Hematology