Recall Monitor
Health Products

Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberMode or catalogue number
Unicel Dxi 600 Access Immunoassay System- Thyroglobulin Assay43916333860

Issue

Multiple customers reported receiving high patient results when using access thyroglobulin reagent pack lot 439163. An internal review of batch records determined this was the first lot released using antibodies produced by BEC instead of a third party supplier. Recall start date: July 2, 2025

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