Official recall record
VITROS Chemistry Product System-Ca Slides (Calcium)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-07-24
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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