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

• 
  Reason
• 
  Affected products

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