Product Wiki · Recalls · Health Canada — Medical Devices

GASTROCCULT 40T (2016-05-02) — recall 55346

Health Canada — Medical Devices · Canada · 2016-05-16 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55346
Date of alert
2016-05-16
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: Beckman Coulter has confirmed an issue where the pH test area for the Gastroccult kit may display an unexpected color for a sample at a pH 7 reading when compared to the associated section of the color comparator bar. A sample with a pH 7 may exhibit a brownish-yellow color reading instead of the expected olive green color. The issue was first reported by a US account in March 2015 but the issue was escalated due to trending observed in January 2016.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/gastroccult-40t-2016-05-02

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