Medical device recall in Canada: STA products may show incorrect results
In plain language
This recall involves System Control N+P, STA - Coag Control N+P and Unicalibrator - STA medical devices sold in Canada. They are being recalled because they may show incorrect test results for factor VIII or IX. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot and model numbers.
- Contact Diagnostica Stago SAS for return instructions.
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Affected products
System Control N+P, STA - Coag Control N+P
Model: 678
Lot: 253145, 253416, 253655, 254040, 254206, 254401, 254573, 254760
Unicalibrator, STA
Model: 675
Lot: 253180, 253964, 254721, 255108
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: 253145, 253416, 253655, 254040, 254206, 254401, 254573, 254760, 253180, 253964, 254721, 255108
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 675, 678
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 the lot and model numbers. Contact Diagnostica Stago SAS for return 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 December 13, 2019.
Is the STA brand affected by this recall?
Yes, STA products are affected by this recall. This recall involves System Control N+P, STA - Coag Control N+P and Unicalibrator - STA medical devices sold in Canada. They are being recalled because they may show incorrect test results for factor VIII or IX. Stop using the product and follow the return steps in the official notice.