Beckman Coulter Thyroglobulin Assay recall in Canada: Performance issue
In plain language
This recall involves Beckman Coulter Thyroglobulin Assay kits used with Unicel Dxi and Access Immunoassay Systems. It's being recalled because an internal investigation found that the calibrator card causes a decrease in patient results. Healthcare professionals should contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
Unicel Dxi 600 Access Immunoassay System - Thyroglobulin Assay
Lot: 234355, 233806, 234171, 234443, 234444, 234617, 337940, 33865
Access System - Thyroglobulin Assay
Lot: 234355, 233806, 234171, 234443, 234444, 234617, 337940, 33865
Unicel Dxi 800 Access Immunoassay System - Thyroglobulin Assay
Lot: 234355, 233806, 234171, 234443, 234444, 234617, 337940, 33865
Why this matters
Performance issue
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: 234355, 233806, 234171, 234443, 234444, 234617, 337940, 33865
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?
Performance issue
What should consumers do?
Contact the manufacturer if you require additional 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. Performance issue
When was this product recalled?
This product was recalled on July 19, 2023.
Is the BECKMAN COULTER, INC. brand affected by this recall?
Yes, BECKMAN COULTER, INC. products are affected by this recall. This recall involves Beckman Coulter Thyroglobulin Assay kits used with Unicel Dxi and Access Immunoassay Systems. It's being recalled because an internal investigation found that the calibrator card causes a decrease in patient results. Healthcare professionals should contact the manufacturer for more information.