Cobas Infinity Central Lab recall in Canada: Medical device issue
In plain language
This recall involves the Cobas Infinity Central Lab medical device sold in Canada. It's being recalled because of a software issue that could incorrectly assign alarm codes. Healthcare professionals should stop using the affected software versions and follow the instructions in the official notice.
What to do
- Stop using the affected software immediately.
- Check the model and software version of your device.
- Follow the instructions from Roche Diagnostics GMBH.
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Affected products
Cobas Infinity Central Lab
Model: 7154003001
Date codes: Software vers.:3.00.00-3.01.02
Why this matters
Incorrect alarm code assignment
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 date code
Date codes are usually printed near the best-before date or on the packaging seam.
Affected date codes: Software vers.:3.00.00-3.01.02
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 7154003001
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 alarm code assignment
What should consumers do?
Stop using the affected software immediately. Check the model and software version of your device. Follow the instructions from Roche Diagnostics GMBH.
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 alarm code assignment
When was this product recalled?
This product was recalled on October 25, 2019.
Is the Cobas Infinity brand affected by this recall?
Yes, Cobas Infinity products are affected by this recall. This recall involves the Cobas Infinity Central Lab medical device sold in Canada. It's being recalled because of a software issue that could incorrectly assign alarm codes. Healthcare professionals should stop using the affected software versions and follow the instructions in the official notice.