Product Wiki · Recalls · Health Canada — Medical Devices

Alinity i Processing Module (2018-09-18) — recall 58227

Health Canada — Medical Devices · Canada · 2018-10-05 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
58227
Date of alert
2018-10-05
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Abbott has identified an issue with the Alinity i bulk solution Dispense Pumps (part number A-35001280-01) resulting in pump failures. The issue is linked to the design of an internal seal within the pump that allows a small amount of leakage of bulk solution(s) that eventually results in the pump failure. The amount of the leakage does not impact the ability of the pump to accurately dispense bulk solutions, and the leakage is contained within the service-only area of the instrument. Therefore, this issue does not pose a risk of incorrect results or a risk of physical exposure to the operator. The failure of this pump could result in unexpected instrument down time potentially causing a delay in generating results.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/alinity-processing-module-2018

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