Product Wiki · Recalls · Health Canada — Medical Devices

COULTER S-CAL CALIBRATOR KITS (2015-12-14) — recall 54554

Health Canada — Medical Devices · Canada · 2016-01-18 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54554
Date of alert
2016-01-18
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Beckman Coulter has received an increased number of customer complaints observed after S-CAL calibration on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems, and the COULTER LH 750 and LH 780 Hematology Systems. Customers have reported a variety of issues during calibration, including: an increase in H&H check messages, low MCH recover in XB, and low MCHC recovery in XB. These issues are not observed with all analyzers.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/coulter-s-cal-calibrator-kits-

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