Iron Gen.2 recall in Canada: Medical device may give incorrect results
In plain language
This recall involves Iron Gen.2 medical devices sold in Canada. It's being recalled because it may provide incorrect test results. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model number 03183696122.
- Contact Roche Diagnostics GMBH for instructions.
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Affected products
Iron Gen.2
Model: 03183696122
Lot: All lots
Why this matters
Incorrect medical 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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 03183696122
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 medical test results
What should consumers do?
Stop using the product immediately. Check model number 03183696122. 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. Incorrect medical test results
When was this product recalled?
This product was recalled on May 26, 2021.