UniCel DxI 600 Access Immunoassay System-Total T4 Assay
In plain language
This recall involves the UniCel DxI 600 Access Immunoassay System-Total T4 Assay used in Canada. It's being recalled because it may produce false low patient results. Healthcare professionals should contact the manufacturer for more information.
What to do
- Stop using the affected product immediately.
- Contact the manufacturer for additional information.
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Affected products
UniCel DxI 600 Access Immunoassay System-Total T4 Assay
Model: 33805
Lot: 538729, 538815, 538898, 539107, 539243
Why this matters
False low patient 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: 538729, 538815, 538898, 539107, 539243
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 33805
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?
False low patient results
What should consumers do?
Stop using the affected product immediately. Contact the manufacturer for 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. False low patient results
When was this product recalled?
This product was recalled on March 19, 2026.
Is the BECKMAN COULTER, INC. brand affected by this recall?
Yes, BECKMAN COULTER, INC. products are affected by this recall. This recall involves the UniCel DxI 600 Access Immunoassay System-Total T4 Assay used in Canada. It's being recalled because it may produce false low patient results. Healthcare professionals should contact the manufacturer for more information.