Product Wiki · Recalls · Health Canada — Medical Devices

Chemstrip 5, Chemstrip 7 and Urisys 1100 (2018-08-27) — recall 58856

Health Canada — Medical Devices · Canada · 2018-11-28 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
58856
Date of alert
2018-11-28
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: A deviation was found in measuring performance for above listed test strip products, when measured on Urisys 1100 Urine Analyzer. The performance for Limit of Detection (LoD) of parameter Protein, Nitrite, Leukocytes and Erythrocytes does not correspond to the values listed in the respective registration documents. The discrepant LoD can lead to false negative results at the limit of detection level, for affected parameters (Protein, Nitrite, Leukocytes or Blood (intact erythrocytes)).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/chemstrip-5-chemstrip-7-and-ur

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