Product Wiki · Recalls · Health Canada — Medical Devices

VITROS Chemistry Products PHYT Slides (2018-05-10) — recall 61014

Health Canada — Medical Devices · Canada · 2018-06-06 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61014
Date of alert
2018-06-06
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Ortho confirmed customer complaints regarding the potential for imprecise results when using specific lots of the VITROS PHYT Slides. Ortho performed internal testing to confirm the issue using several lots of coating 0165. The results obtained were either positively or negatively biased across the VITROS PHYT Slides measuring range of 3.00-40.00 ug/ml (11.88-158.40 umol/l).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitros-chemistry-products-phyt

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