Product Wiki · Recalls · Health Canada — Medical Devices

Elecsys Anti-TSHR (2018-08-21) — recall 58708

Health Canada — Medical Devices · Canada · 2019-01-11 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
58708
Date of alert
2019-01-11
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Following internal investigation of customer complaints, the manufacturer confirmed a limitation in On-Board Stability (OBS) of the product Elecsys Anti-TSHR (#07026951190) lot #28356401 used on cobas e 801 module. The OBS could be maintained for 8 weeks, in comparison to the 16 weeks OBS claim as described in the Method Sheet of the assay.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/elecsys-anti-tshr-2018-08-21

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