Product Wiki · Recalls · Health Canada — Medical Devices

Alinity ci-Series System Control Module (2019-05-23) — recall 59243

Health Canada — Medical Devices · Canada · 2019-06-07 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59243
Date of alert
2019-06-07
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 all on market versions of Alinity ci-series software where the software may not detect an issue on the Alinity c integrated chip technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-). Abbott will be releasing Alinity ci-series software version 2.6.1 to change the ICT reference solution voltage drift threshold from 10mV to 3mV to improve the ability of the system to detect ICT reference solution voltage drift. ICT issues may cause incorrect patient results for the Na+, K+, and Cl- assays for all specimen types (serum, plasma, and urine).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/alinity-ci-series-system-contr

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