Product Wiki · Recalls · Health Canada — Medical Devices

COBAS KRAS MUTATION TEST (2015-06-16) — recall 53934

Health Canada — Medical Devices · Canada · 2015-07-08 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
53934
Date of alert
2015-07-08
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: Following the routine stability monitoring, the cobas KRAS Mutation Test (cat # 05852170190, lot t15475) was identified to be generating invalid results for the mutant control and/or KRAS calibrator at a much higher rate than expected.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-kras-mutation-test-2015-

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