Product Wiki · Recalls · Health Canada — Medical Devices

VITROS Chemistry Products dTIBC Reagent (2016-05-25) — recall 55130

Health Canada — Medical Devices · Canada · 2016-06-24 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55130
Date of alert
2016-06-24
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Ortho Clinical Diagnostics (Ortho) has initiated this recall due to the potential for positively biased results generated when using VITROS dTIBC Reagent, Gen 30. Ortho determined that there are incorrect values (data/calibration mathematics) on assay data diskettes (add) for VITROS Calibrator Kit 29 that support VITROS dTIBC Reagent, Gen 30. The incorrect values will cause a positive bias in sample results (i.e., patient samples, proficiency fluids and quality control fluids).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitros-chemistry-products-dtib

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