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Unicel dxi 600 access immunoassay system-total t4 assay
Official notice
19 Mar 2026
Last checked
19 Mar 2026
An official Health Canada notice concerns Unicel dxi 600 access immunoassay system-total t4 assay. 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. Published 2026-03-19.
What to do now
Contact the manufacturer if you require additional information.
Recall number
81777
Official notice
2026-03-19
The hazard
The hazard
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.
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
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Company & contacts
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Brand: Beckman Coulter.
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Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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