Recall Monitor
Health Products

UniCel DxI 600 Access Immunoassay System-Total T4 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-Total T4 Assay
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Get told about the next health product recall.

We email or text you when Canada issues a recall that matches what you watch: a brand, a product, an allergen. Most never make the news.

Get health product recall alerts

CA$3.99/mo · cancel anytime

Products

Affected productsLot or serial numberModel or catalogue number
UniCel DxI 600 Access Immunoassay System-Total T4 Assay53881533805
UniCel DxI 600 Access Immunoassay System-Total T4 Assay53924333805
UniCel DxI 600 Access Immunoassay System-Total T4 Assay53872933805
UniCel DxI 600 Access Immunoassay System-Total T4 Assay53889833805
UniCel DxI 600 Access Immunoassay System-Total T4 Assay53910733805

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.

Get told about the next health product recall.
Get health product recall alerts

CA$3.99/mo · cancel anytime