Product Wiki · Recalls · Health Canada — Medical Devices

Vitros 5600 and 4600 Integrated System (2014-09-09) — recall 52432

Health Canada — Medical Devices · Canada · 2014-09-22 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
52432
Date of alert
2014-09-22
Country / jurisdiction
Canada
Authority classification
Type II
Notice 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 (OCD) has identified an anomaly with Vitros system software version 3.0 and below. Internal testing confirmed that when using calibrator barcode labels supplied with Vitros chemistry products calibrator kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned. Consignees are being instructed not to use the calibrator barcode labels for Vitros calibrator kits 1, 2, 3, 4, 6, or 9 until the next version of software is installed on their Vitros system.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitros-5600-and-4600-integrate

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