Product Wiki · Recalls · Health Canada — Medical Devices

Cobas U Cuvette (400 Pc) — recall 76511

Health Canada — Medical Devices · Canada · 2024-11-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
76511
Date of alert
2024-11-14
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: The manufacturer reported a possible contamination with small plastic particles in cuvettes of Cobas U Cuvette (400 pc) lot 24016700 . These particles will be recognized as crystals by the analyzer's microscope and its algorithm. The issue can lead to erroneous positive results for crystals in urine. Recall start date: November 4, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-u-cuvette-400-pc

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