ARCHITECT Total and Free T3 Reagent Kit (2018-10-16)
In plain language
This recall involves ARCHITECT Total T3 Reagent Kit and ARCHITECT Free T3 Reagent Kit sold in Canada. They are being recalled because reagent cross-contamination can lead to inaccurate test results. Healthcare professionals should stop using the affected products and follow the instructions in the official notice.
What to do
- Stop using the affected products immediately.
- Refer to the official recall notice for detailed instructions.
- Contact Abbott Ireland Diagnostic Division for more information.
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Affected products
ARCHITECT Total T3 Reagent Kit
Model: 7K64-20, 7K64-25, 7K64-27, 7K64-30, 7K64-32, 7K64-35, 7K64-37
Lot: All lots
ARCHITECT Free T3 Reagent Kit
Model: 7K63-20, 7K63-25, 7K63-27, 7K63-30, 7K63-32, 7K63-35, 7K63-37
Lot: All lots
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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 7K63-20, 7K63-25, 7K63-27, 7K63-30, 7K63-32, 7K63-35, 7K63-37, 7K64-20, 7K64-25, 7K64-27, 7K64-30, 7K64-32, 7K64-35, 7K64-37
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 affected products immediately. Refer to the official recall notice for detailed instructions. Contact Abbott Ireland Diagnostic Division 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?
Yes, there may be a health risk. Inaccurate test results
When was this product recalled?
This product was recalled on November 2, 2018.
Is the ARCHITECT brand affected by this recall?
Yes, ARCHITECT products are affected by this recall. This recall involves ARCHITECT Total T3 Reagent Kit and ARCHITECT Free T3 Reagent Kit sold in Canada. They are being recalled because reagent cross-contamination can lead to inaccurate test results. Healthcare professionals should stop using the affected products and follow the instructions in the official notice.