Product Wiki · Recalls · Health Canada — Medical Devices

Sysmex Urine Quality Control and Calibrator (2018-11-19) — recall 58885

Health Canada — Medical Devices · Canada · 2018-12-10 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
58885
Date of alert
2018-12-10
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/sysmex-urine-quality-control-a

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