Product Wiki · Recalls · Health Canada — Medical Devices

Vitros 5600 Integrated Systems (2014-09-30) — recall 52102

Health Canada — Medical Devices · Canada · 2014-10-09 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
52102
Date of alert
2014-10-09
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 (OCD) has identified an anomaly with Vitros system software version 3.1. Internal testing confirmed that when using calibrator barcode labels supplied with Vitros chemistry products calibrator kit 2, calibration may not occur under specific circumstances. Consignees are being advised not to use the calibrator barcode labels for Vitros calibrator kit 2 until this anomaly is resolved in a future version of software.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitros-5600-integrated-systems

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