Recall Monitor
Health Products

VITROS Chemistry Product System-Ca Slides (Calcium)

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: VITROS Chemistry Product System-Ca Slides (Calcium)
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 numberModel or catalogue number
VITROS Chemistry Product System-Ca Slides (Calcium)Gen 67 and above145 0261

Issue

Generations (Gens) 67 and above of VITROS CA slides may experience an increased occurrence of condition code th4-63j during calibration, on VITROS XT 3400 and VITROS XT 7600 systems. Condition code th4-63j is generated when the reflectometer detects image variations which exceed an assay parameter defined on the assay data disk (add). If condition code th4-63j is generated during calibration, the calibration may fail. Recall start date: July 14, 2025

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