ARCHITECT and Alinity i Reagent Kits recall in Canada: inaccurate test results
In plain language
This recall involves ARCHITECT HAVAb-IgG, ARCHITECT HAVAb-IgM, and Alinity i HAVAb IgG Reagent Kits sold in Canada. They are being recalled because a manufacturing error may cause falsely elevated test results. Stop using the affected products and follow the instructions in the official notice.
What to do
- Stop using the product immediately.
- Check the lot and model numbers provided.
- Contact Abbott for further instructions.
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Affected products
ARCHITECT HAVAb-IgG Reagent Kit
Model: 6C29-22, 6C29-27
Lot: 90356LI00, 90360LI00
ARCHITECT HAVAb-IgM Reagent Kit
Model: 6C30-22, 6C30-27
Lot: 90227LI00, 90228LI00, 91012LI00, 91013LI00
Alinity i HAVAb IgG Reagent Kit
Model: 08P2632
Lot: 90385LI00
Why this matters
Inaccurate 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: 90227LI00, 90228LI00, 91012LI00, 91013LI00, 90356LI00, 90360LI00, 90385LI00
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 08P2632, 6C29-22, 6C29-27, 6C30-22, 6C30-27
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?
Inaccurate test results
What should consumers do?
Stop using the product immediately. Check the lot and model numbers provided. Contact Abbott for further 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. Inaccurate test results
When was this product recalled?
This product was recalled on October 26, 2018.
Is the ARCHITECT, Alinity i brand affected by this recall?
Yes, ARCHITECT, Alinity i products are affected by this recall. This recall involves ARCHITECT HAVAb-IgG, ARCHITECT HAVAb-IgM, and Alinity i HAVAb IgG Reagent Kits sold in Canada. They are being recalled because a manufacturing error may cause falsely elevated test results. Stop using the affected products and follow the instructions in the official notice.