MedFDAWatch
← Back to Medical Device Explorer

SYSMEX AMERICA INC

XE-5000 · General Hospital

510(k): 1 Recall: 3 UDI: 0 MAUDE: 0 Class.: 66

510(k) Clearances (1)

SYSMEX XE-5000
2007-11-20

Substantially Equivalent

Recalls (3)

Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening
2012-06-01

There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.

Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SI
2011-04-11

The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.

Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SI
2009-06-23

The affected lots of Stromatolyser-IM lysing reagent was found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.

FDA Classification (66)

Digital Physical/Chemical Sterilization Process Sensor

General Hospital

Set, Blood Transfusion

General Hospital

Washer Of Body Waste Receptacles

General Hospital

Sterilizer, Dry Heat

General Hospital

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

General Hospital

Infusion Safety Management Software

General Hospital

Vascular Access Port Kit

General Hospital

Tubing, Fluid Delivery

General Hospital

Basin, Emesis

General Hospital

Oral Administration Set

General Hospital

Ear Irrigation Kit

General Hospital

Nursing Pad, Cohesive Gel

General Hospital

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

General Hospital

Bottle, Collection, Vacuum

General Hospital

Thoracentesis Tray

General Hospital

Delivery Room Apparel Kit

General Hospital

Support, Scrotal, Therapeutic

General Hospital

Whole Room Microbial Reduction Device

General Hospital

Detectors And Removers, Lice, (Including Combs)

General Hospital

Accessories To Examination Light

General Hospital

Stocking, Medical Support (For General Medical Purposes)

General Hospital

Blood Borne Pathogen Response Kit

General Hospital

Strip, Temperature, Forehead, Liquid Crystal

General Hospital

Pump, Infusion, Pca

General Hospital

Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

General Hospital

Stationary Infrared Thermometer

General Hospital

Depressor, Tongue, Non-Surgical

General Hospital

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

General Hospital

Low Dead Space Needle, Single Lumen, Hypodermic

General Hospital

Warmer, Infant Radiant

General Hospital

Tubing, Noninvasive

General Hospital

Administrations Sets With Neuraxial Connectors

General Hospital

Stapler, Surgical

General Hospital

Warmer, Thermal, Infusion Fluid

General Hospital

Rigid Sterilization Container With Software

General Hospital

Lubricant, Vaginal, Patient

General Hospital

Sterilizer, Steam

General Hospital

Mattress, Water, Temperature Regulated

General Hospital

Heparin Flush In 0.45% Sodium Chloride

General Hospital

Powder-Free Guayle Rubber Examination Glove

General Hospital

Thermometer Kit

General Hospital

Automated Endoscope Channel Cleaner

General Hospital

Cover, Mattress (Medical Purposes)

General Hospital

Fall Prevention Alarm/Sensor Attached Only

General Hospital

Rfid Chip For Dental Appliance

General Hospital

Bed, Manual

General Hospital

Indicator, Biological, Liquid Chemical Sterilization Process

General Hospital

Mid-Stream Collection Kit

General Hospital

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

General Hospital

Central Venous Catheter Dressing Change Kit

General Hospital

Bottle, Hot/Cold Water

General Hospital

Chamber, Reverse Isolation, Patient Care

General Hospital

Peripheral Catheter Insertion Kit

General Hospital

Kit, Chemical Snake-Bite

General Hospital

Body Temperature Sensing Software

General Hospital

Image Processing Device For Estimation Of External Blood Loss

General Hospital

Lubricant, Patient

General Hospital

Oral Lubricant

General Hospital

Implantable Radio Frequency Transponder System

General Hospital

Water, Vascular Access Flush

General Hospital

Buret Administration Intravenous Kit

General Hospital

Allergen And Vaccine Delivery Needles

General Hospital

Bed, Ac-Powered Adjustable Hospital

General Hospital

Mattress And Bed Deck Cover (Medical Purposes)

General Hospital

Unit, Neonatal Phototherapy

General Hospital

Infant Positioner, Rx, Use In Highly Monitored Setting

General Hospital