Product Wiki · Recalls · Health Canada — Medical Devices

VITROS Integrated/ Chemistry Systems (2015-12-21) — recall 54759

Health Canada — Medical Devices · Canada · 2016-01-25 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54759
Date of alert
2016-01-25
Country / jurisdiction
Canada
Risk level
Type II
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, inc. (ortho) initiated this urgent product correction notification due to the need to clarify operator actions following U90-382 or 6LU condition codes generated by the systems affected by this recall. U90-382 or 6LU condition codes are associated with wash errors that may occur when using VITROS chemistry products for Immuno-Rate assays (i.e. VITROS, CRBM, CRP, DGXN, and PHYT slides). If a U90-382 or 6LU condition code (i.e., associated with a wash error) occurs, the condition code text located on the VITROS system and other user documentation indicates to dilute the sample. However, dilution may not be the appropriate action for all scenarios.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitros-integrated-chemistry-sy

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