Medical device recall in Canada: COBAS analyzers
In plain language
This recall involves COBAS INTEGRA 400 plus Analyzer and COBAS C 111 Stand Alone Configuration medical devices sold in Canada. They are being recalled because different types of carryover were discovered. 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.
- Return, repair, or dispose of it as instructed.
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Affected products
COBAS INTEGRA 400 plus Analyzer
Model: 03245233001
Lot: All serial numbers
COBAS C 111 Stand Alone Configuration
Model: 04528778001
Lot: All serial numbers
COBAS C 111 with ISE Stand Alone Configuration
Model: 04777433001
Lot: All serial numbers
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 serial numbers
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 03245233001, 04528778001, 04777433001
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?
This recall involves COBAS INTEGRA 400 plus Analyzer and COBAS C 111 Stand Alone Configuration medical devices sold in Canada. They are being recalled because different types of carryover were discovered. Stop using the product and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the product immediately. Check model numbers. Return, repair, or dispose of it as instructed.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on January 9, 2019.
Is the COBAS brand affected by this recall?
Yes, COBAS products are affected by this recall. This recall involves COBAS INTEGRA 400 plus Analyzer and COBAS C 111 Stand Alone Configuration medical devices sold in Canada. They are being recalled because different types of carryover were discovered. Stop using the product and follow the return/repair steps in the official notice.