Product Wiki · Recalls · Health Canada — Medical Devices

ImmunoCAP Allergen c6, Amoxicilloyl and c5, Ampicilloyl (2017-12-28) — recall 57597

Health Canada — Medical Devices · Canada · 2018-01-12 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
57597
Date of alert
2018-01-12
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Somagen Diagnostics along with Thermofisher Scientific would like to notify you of an urgent recall and backorder of ImmunoCAP Allergen c5, Ampicilloyl product code 14-4450-01 and ImmunoCAP Allergen c6, Amoxicilloyl product code 14-4451-01. An internal monitoring stability study has indicated that stability specifications have not been met and were in fact half the intended expiry date of 12 months. There is a possibility that samples with a low positive concentration may be incorrectly reported as negative. Any reported test results below the assay Limit of Qualification (LOQ) should be disregarded as these results may be invalid. No complaints or injuries to patients have been reported.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/immunocap-allergen-c6-amoxicil

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