Product Wiki · Recalls · Health Canada — Medical Devices

Ammonia L3K Assay — recall 44376

Health Canada — Medical Devices · Canada · 2016-12-13 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
44376
Date of alert
2016-12-13
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Internal testing performed by Sekisui Diagnostics has determined that certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ammonia-l3k-assay

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