CgA-ELISA and ALDO-RIACT (2018-11-22)
In plain language
This recall involves CgA-ELISA and ALDO-RIACT medical devices sold in Canada. They are being recalled because exogen biotin can interfere with test results, leading to incorrect readings. Stop using the products and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers CgA-ELISA and ALDO-RIACT.
- Return the products as instructed.
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Affected products
CgA-ELISA
Model: CGA-ELISA
Lot: All lots
ALDO-RIACT
Model: ALDO-RIACT
Lot: All lots
Why this matters
Incorrect 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: ALDO-RIACT, CGA-ELISA
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 test results
What should consumers do?
Stop using the product immediately. Check model numbers CgA-ELISA and ALDO-RIACT. Return the products 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?
Yes, there may be a health risk. Incorrect test results
When was this product recalled?
This product was recalled on December 10, 2018.