BIO-RAD LABORATORIES INC

PHD SYSTEM · Hematology

510(k): 0 Recall: 2 UDI: 0 MAUDE: 1 Class.: 56

Recalls (2)

PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer via an Ethernet hub. The network computer provides worklist generation, data management, data red

2011-01-20

Firm's Correction involves advising customers who have implemented a Laboratory Information System (LIS) that they need to ensure quantitative results have passed all validation criteria prior to reporting patient results. When a patient result fails a Validation Rule, the qualitative result will indicate "INVALID".

PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. Manufactured by Bio-Rad Laboratories, France, Distributed by Bio-Rad Laboratories, Hercules, CA. EIA and IFA processing system that consists of a PhD fluid handling station (s) linked to a netw

2009-09-29

Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme immunoassays on the PhD system with software version 2.1A.

MAUDE Adverse Events (1)

Other

20110110

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