COBAS 6500 ANALYZER (2021-05-26)
In plain language
This recall involves the COBAS 6500 Analyzer, specifically the u601 and u701 models, used in Canada. It's being recalled because a software issue could lead to incorrect sample results. This could affect medical decisions for patients.
What to do
- Stop using the product immediately.
- Check model and software version numbers.
- Follow the return/repair steps in the official notice.
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Affected products
COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZER
Model: 6390498001
Lot: software version ≥ 2.3.6.
COBAS 6500 - COBAS U701 MICROSCOPY ANALYZER
Model: 6390501001
Lot: software version ≥ 2.3.6.
Why this matters
Incorrect test results affecting medical decisions
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: software version ≥ 2.3.6.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 6390498001, 6390501001
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 affecting medical decisions
What should consumers do?
Stop using the product immediately. Check model and software version numbers. Follow the return/repair steps in the official notice.
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 affecting medical decisions
When was this product recalled?
This product was recalled on June 10, 2021.
Is the COBAS brand affected by this recall?
Yes, COBAS products are affected by this recall. This recall involves the COBAS 6500 Analyzer, specifically the u601 and u701 models, used in Canada. It's being recalled because a software issue could lead to incorrect sample results. This could affect medical decisions for patients.