Product Wiki · Recalls · Health Canada — Medical Devices

Cobas IT Middleware — recall 56349

Health Canada — Medical Devices · Canada · 2017-03-16 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
56349
Date of alert
2017-03-16
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: In specific circumstances, the evaluation of QC Westgard rules can be performed incorrectly. Rules comparing a quality control result with a previous result (or results) can be incorrectly assessed out of sequence. Rules to assess a rising or falling trend in quality control results can also be wrongly evaluated. However, the result released is correct.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-it-middleware

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