UniCel DxI 600, 800 Access Immunoassay Systems (Thyroglobulin Antibody II, Free T3 Assay, Free T4 Assay, Total T3 Assay, Thyroglobulin Assay, GI Monitor (CA 19-9))(2019-04-22)
In plain language
This recall involves UniCel DxI 600 and 800 Access Immunoassay Systems and related assay kits sold in Canada. They are being recalled because high levels of biotin in patient samples can interfere with test results, leading to falsely elevated or decreased readings. Healthcare professionals should be aware of this potential interference when interpreting results.
What to do
- Stop using the affected products if you are a healthcare professional.
- Review the official recall notice for detailed information on affected assays and potential interference levels.
- Consider patient biotin intake when interpreting test results from these systems.
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Affected products
Specific affected products are listed in the official notice.
Why this matters
Incorrect test results
Do I have this product?
This recall applies to specific products. Details are listed in the official notice.
Frequently Asked Questions
Why was this product recalled?
Incorrect test results
What should consumers do?
Stop using the affected products if you are a healthcare professional. Review the official recall notice for detailed information on affected assays and potential interference levels. Consider patient biotin intake when interpreting test results from these systems.
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.