UniCel DxI 600 Total T4 Assay Recall
Summary
Health Canada has issued a Type II recall for the UniCel DxI 600 Access Immunoassay System-Total T4 Assay due to a negative bias that can cause false low patient results. The recall affects specific lot numbers and poses a medium safety risk. Healthcare providers are advised to contact the manufacturer for further information.
What changed
Health Canada has issued a Type II recall for Beckman Coulter's UniCel DxI 600 Access Immunoassay System-Total T4 Assay, identified by lot numbers 538815, 539243, 538729, 538898, and 539107 (Model/Catalogue number 33805). The issue stems from Access Total T4 calibrator lots exhibiting a negative bias on DxI 600/800 instruments, leading to potential false low patient results. This performance issue presents a medium safety risk.
Healthcare providers using this system should be aware of the potential for inaccurate low thyroid hormone readings. While no specific action is mandated beyond contacting the manufacturer for information, awareness of this recall is critical for patient safety. The recall was published on March 10, 2026, with an original publication date of March 19, 2026.
What to do next
- Contact the manufacturer for additional information regarding the affected lots.
Source document (simplified)
Health product recall
UniCel DxI 600 Access Immunoassay System-Total T4 Assay
Brand(s)
Last updated
2026-03-19
Summary
Product UniCel DxI 600 Access Immunoassay System-Total T4 Assay Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.
Audience Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| UniCel DxI 600 Access Immunoassay System-Total T4 Assay | 538815 | 33805 |
| UniCel DxI 600 Access Immunoassay System-Total T4 Assay | 539243 | 33805 |
| UniCel DxI 600 Access Immunoassay System-Total T4 Assay | 538729 | 33805 |
| UniCel DxI 600 Access Immunoassay System-Total T4 Assay | 538898 | 33805 |
| UniCel DxI 600 Access Immunoassay System-Total T4 Assay | 539107 | 33805 |
Issue
Access Total T4 calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. In the worst-case scenario, there is a medium safety risk associated with this issue due to the potential to cause false low patient results.
Additional information
Details
Original published date:
2026-03-19
Alert / recall type Health product recall Category Health products - Medical devices - Chemistry Companies
| Beckman Coulter, Inc. |
| 250 S. Kraemer Blvd., Brea, California, United States, 92821 |
Published by Health Canada Audience Healthcare Recall class Type II Recall date
2026-03-10
Identification number RA-81777
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