Health product recall

Sysmex Urine Quality Control and Calibrator (2018-11-19)

Starting date:
November 19, 2018
Posting date:
December 10, 2018
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-68550

Affected products

A. Sysmex Urine Quality Control
B. Sysmex Urine Calibrator

Reason

Sysmex received a complaint from their customers regarding failing Quality Control (QC) for the Red Blood Cells (RBC), White Blood Cells (WBC), Epithelial Cells (EC), casts (CAST) and bacterial (BACT) with the UF II Control. The control failures were for one or a combination of parameters that recovered values on the high side of the printed assay ranges. The manufacturer of the Sysmex UF-1000i has confirmed that the UF II Control and UF II Calibrator Assay targets and limits for the lot numbers YS8029, YS8032, YS8033, and S8023 have been incorrectly assigned during the manufacturing process. This incorrect assignment may cause QC results to recover outside the printed assay ranges.

Affected products

A. Sysmex Urine Quality Control

Lot or serial number

YS8028
YS8029
YS8032
YS8033

Model or catalog number

064-0411-5

Companies
Manufacturer
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN

B. Sysmex Urine Calibrator

Lot or serial number

S8023

Model or catalog number

064-0431-0

Companies
Manufacturer
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN