Medical device recall in Canada: Lactate Gen. 2 and Bilirubin Total Gen 3
In plain language
This recall involves Lactate Gen. 2 in CSF and Bilirubin Total Gen 3 (BILT3) medical devices sold in Canada. They are being recalled because new endogenous interferences were found when used on COBAS INTEGRA 400 plus and COBAS c111. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and lot numbers.
- Contact Roche Diagnostics GMBH for more information.
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Affected products
Lactate Gen. 2 in CSF
Model: 3183700190
Lot: 33763601, 35514701, 37432001, 37432101, 38897701
Bilirubin Total Gen 3 (BILT3)
Model: 5795397190, 5795648190
Lot: More than 10 numbers, contact manufacturer.
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: 33763601, 35514701, 37432001, 37432101, 38897701, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 3183700190, 5795397190, 5795648190
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 Lactate Gen. 2 in CSF and Bilirubin Total Gen 3 (BILT3) medical devices sold in Canada. They are being recalled because new endogenous interferences were found when used on COBAS INTEGRA 400 plus and COBAS c111. Stop using the product and follow the return steps in the official notice.
What should consumers do?
Stop using the product immediately. Check model and lot numbers. Contact Roche Diagnostics GMBH for more information.
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 June 7, 2019.