ARCHITECT Processing Modules recall in Canada: May cause incorrect test results
In plain language
This recall involves ARCHITECT c8000, c16000, and c4000 Processing Modules used in medical settings in Canada. They are being recalled because a software issue could lead to incorrect test results if an error message is not properly resolved. Healthcare professionals should follow the instructions in the official notice to ensure correct operation.
What to do
- Stop using the product if error codes 3580-3585 or 5381 appear without resolution.
- Refer to the ARCHITECT operations manual section 10 for error resolution.
- Contact Abbott Laboratories Diagnostcis Division for more information if needed.
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Affected products
ARCHITECT c8000 Processing Module
Model: 01G06-01, 01G06-11
Lot: More than 10 numbers, contact manufacturer.
ARCHITECT c16000 Processing Module
Model: 03L77-01, 03L77-84
Lot: More than 10 numbers, contact manufacturer.
ARCHITECT c4000 Processing Module
Model: 02P24-01, 02P24-40
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Potential for 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: More than 10 numbers, contact manufacturer.
- 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, 03L77-84
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?
Potential for incorrect test results
What should consumers do?
Stop using the product if error codes 3580-3585 or 5381 appear without resolution. Refer to the ARCHITECT operations manual section 10 for error resolution. Contact Abbott Laboratories Diagnostcis Division for more information if needed.
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. Potential for incorrect test results
When was this product recalled?
This product was recalled on August 17, 2018.
Is the ARCHITECT brand affected by this recall?
Yes, ARCHITECT products are affected by this recall. This recall involves ARCHITECT c8000, c16000, and c4000 Processing Modules used in medical settings in Canada. They are being recalled because a software issue could lead to incorrect test results if an error message is not properly resolved. Healthcare professionals should follow the instructions in the official notice to ensure correct operation.