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Sysmex UF-100 Instrument Manager Software (2013-11-06)
- Starting date:
- November 6, 2013
- Posting date:
- December 5, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36927
Recalled Products
Instrument Manager Software using the Sysu100I Driver that connects to the Sysmex UF-100 Instrument
Reason
When results of "---.-" are received from the Sysmex UF-100 instrument and if the user set the driver configuration option "Strip zeros from result" to "Yes", all versions prior to V7.00.0006 and V8.00.0005 of the SYSU100I driver convert the results to "0.00" in instrument manager. The Sysmex UF-100 will send "--.-" when the test has a sample error. All five urinalysis tests performed (RBC, WBC, Ec, Cast, and Bact) will be resulted as "0.00" in instrument manager. This could lead to misdiagnosis and mistreatment of a patient.
Affected products
Instrument Manager Software using the Sysu100I Driver that connects to the Sysmex UF-100 Instrument
Lot or serial number
N/A
Model or catalog number
7.00.0001
7.00.0002
7.00.0003
7.00.0004
7.00.0005
8.00.0001
8.00.0002
8.00.0003
8.00.0004
Companies
- Manufacturer
-
Data Innovations LLC
120 Kimball Ave. Suite 100
South Burlington
05403
Vermont
UNITED STATES