UX-2000 Fully Automated Integrated Urine Analyzer (2019-09-18)

Starting date:

September 18, 2019

Posting date:

October 11, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71231

Last updated: 2019-10-11

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  Reason
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  Affected products

Affected Products

UX-2000 Fully Automated Integrated Urine Analyzer

Reason

Sysmex America, INC. Received a field correction from the manufacturer Sysmex Corporation, Japan (S-CORP) for an issue with UX-2000 software in which patient demographics (name, birthdate, age, etc.) may lead to a sample mismatch event.

Affected products