Cobas U Cuvette (400 Pc)
Brand(s)
Last updated
Summary
Product
Cobas U Cuvette (400 Pc)
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Cobas U Cuvette (400 Pc) |
24016700 |
06390552001 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
| Roche Diagnostics Gmbh |
| Sandhoferstrasse 116, Mannheim, Germany, 68305 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76511
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