Cobas 6500 Cobas u 601 and u 701 recall in Canada: Inaccurate test results
In plain language
This recall involves Cobas 6500 Cobas u 601 and u 701 medical devices sold in Canada. They are being recalled because a software issue may lead to samples not being measured correctly. 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 and software versions.
- Contact Roche Diagnostics GMBH for instructions.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
Cobas 6500 Cobas u 601
Model: 06390498001
Lot: software version 2.2.3, software version 2.2.4, software version 2.2.5
Cobas 6500 Cobas u 701
Model: 06390501001
Lot: software version 2.2.3, software version 2.2.4, software version 2.2.5
Why this matters
Inaccurate 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: software version 2.2.3, software version 2.2.4, software version 2.2.5
- 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?
Inaccurate test results
What should consumers do?
Stop using the product immediately. Check model numbers and software versions. Contact Roche Diagnostics GMBH 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. Inaccurate test results
When was this product recalled?
This product was recalled on July 27, 2018.
Is the Cobas brand affected by this recall?
Yes, Cobas products are affected by this recall. This recall involves Cobas 6500 Cobas u 601 and u 701 medical devices sold in Canada. They are being recalled because a software issue may lead to samples not being measured correctly. Stop using the product and follow the return/repair steps in the official notice.