Product Wiki · Recalls · Health Canada — Medical Devices

Chemstrip 10A and Urisys 1100 Analyzer (2018-05-10) — recall 61044

Health Canada — Medical Devices · Canada · 2018-06-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61044
Date of alert
2018-06-14
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: It was discovered during internal performance studies that the Limit Of Detection (LOD) of the Chemstrip 10A needs to be changed since the current performance claim showed deviating values for protein, nitrite, ketone bodies, leukocytes, blood (intact erythrocytes) when measured on Urisys 1100 analyzer.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/chemstrip-10a-and-urisys-1100-

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