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Health Canada Medical devices

Cobas U Cuvette (400 Pc)

Issued November 14, 2024
Issue
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
Hazard description
Performance
Product
Product name
Cobas U Cuvette (400 Pc)
Reference
ID
RA-76511