Product Wiki · Recalls · Health Canada — Medical Devices

Elecsys Anti-Tg (2019-07-29) — recall 59875

Health Canada — Medical Devices · Canada · 2019-08-23 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
59875
Date of alert
2019-08-23
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: During a routine internal quality control procedure, a potential performance problem with the Elecsys Anti-Tg of lot number 406816 was identified. This may lead to a significant drop of the calibration signals resulting in low control recoveries. This lot was never distributed to customers in Canada, but since it was imported in Canada, we are issuing this as a manufacturer recall. The manufacturer advised us about this issue on 19-Jul-2019.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/elecsys-anti-tg-2019-07-29

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