Health Canada — Medical Devices · Canada · 2016-05-30 · Type III
As described by Health Canada — Medical Devices: VITROS Immunodiagnostic Products AFP Reagent Pack and Calibrators (2016-05-10)
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Reported risk: Ortho Clinical Diagnostics (Ortho) has initiated this recall due to the potential of an inability to obtain a valid calibration when using VITROS AFP Reagent Packs: - VITROS Immunodiagnostic Products AFP Reagent Pack, lot 1440 - VITROS Immunodiagnostic Products AFP Calibrators, lot 1440 Ortho confirmed that this lot exhibited an increase in reaction signal over time. Initial testing indicates that the unexpected signal increase is related to a specific lot of raw material used in the manufacture of this lot. The affected lot of VITROS AFP Reagent Packs met all quality assurance specifications upon release.
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