Product Wiki · Recalls · Health Canada — Medical Devices

Unicel DXI 600 and DXI 800 Access Immunoassay Systems (2014-01-29) — recall 50733

Health Canada — Medical Devices · Canada · 2014-03-18 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
50733
Date of alert
2014-03-18
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: The Access Thyroglobulin Calibrators are a lyophilized product and as such need to be reconstituted prior to use. The reconstitution time of 30 minutes as stated in the thyroglobulin calibrators instructions for use (IFU) is insufficient for the four affected lots of thyroglobulin calibrators. This has resulted in high patient and control results that are on average greater than 1 standard deviation high.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/unicel-dxi-600-and-dxi-800-acc

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