Cobas 6500 Urinalysis System recall in Canada: sample mismatch risk
In plain language
This recall involves the Cobas 6500 u601 Urinalysis System and Cobas 6500 u701 Microscopy Analyzer. It's being recalled because a sample mismatch could occur between samples. This could lead to incorrect test results being assigned to samples. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers 06390498001 and 06390501001.
- Contact Roche Diagnostics for instructions.
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Affected products
COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE
Model: 06390498001
Lot: All lots
COBAS 6500 U701 MICROSCOPY ANALYZER
Model: 06390501001
Lot: All lots
Why this matters
Incorrect test results
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 06390498001, 06390501001
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Incorrect test results
What should consumers do?
Stop using the product immediately. Check model numbers 06390498001 and 06390501001. Contact Roche Diagnostics for instructions.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Incorrect test results
When was this product recalled?
This product was recalled on February 1, 2018.
Is the Cobas brand affected by this recall?
Yes, Cobas products are affected by this recall. This recall involves the Cobas 6500 u601 Urinalysis System and Cobas 6500 u701 Microscopy Analyzer. It's being recalled because a sample mismatch could occur between samples. This could lead to incorrect test results being assigned to samples. Stop using the product and follow the return/repair steps in the official notice.