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Cobas u cuvette (400 pc)
Official notice
14 Nov 2024
Last checked
14 Nov 2024
An official Health Canada notice concerns Cobas u cuvette (400 pc). 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 Published 2024-11-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76511
Official notice
2024-11-14
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Roche Diagnostics, Cobas U Cuvette.
Source & status
Source & status
Source
Tier
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Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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