ARCHITECT System recall in Canada: incorrect test results
In plain language
This recall involves ARCHITECT System medical devices sold in Canada. They are being recalled because a mixer blade may detach, leading to inadequate mixing and potentially incorrect test results. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers: 01G06-01, 01G06-11, 03L77-01, 02P24-01, 02P24-40.
- Contact Abbott Laboratories Diagnostics Division for instructions.
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Affected products
ARCHITECT System - Analyzer - Class 2
Model: 01G06-01, 01G06-11
Lot: All lots
ARCHITECT c16000 - Processing Module
Model: 03L77-01
Lot: All lots
ARCHITECT c4000 System - Processing Module
Model: 02P24-01
Lot: All lots
ARCHITECT c4000 System - Integrated Processing Module
Model: 02P24-40
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: 01G06-01, 01G06-11, 02P24-01, 02P24-40, 03L77-01
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: 01G06-01, 01G06-11, 03L77-01, 02P24-01, 02P24-40. Contact Abbott Laboratories Diagnostics Division 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 test results
When was this product recalled?
This product was recalled on May 17, 2019.
Is the ARCHITECT System brand affected by this recall?
Yes, ARCHITECT System products are affected by this recall. This recall involves ARCHITECT System medical devices sold in Canada. They are being recalled because a mixer blade may detach, leading to inadequate mixing and potentially incorrect test results. Stop using the product and follow the return/repair steps in the official notice.