Product Wiki · Recalls · Health Canada — Medical Devices

BC-THROMBIN REAGENT (2017-10-12) — recall 57531

Health Canada — Medical Devices · Canada · 2017-10-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
57531
Date of alert
2017-10-27
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The BC Thrombin Reagent Kit lots 46751 (contains Thrombin Reagent lot 517468) and Kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged thrombin time results for expected normal samples, and may recover above the upper limit of normal which is 21 sec as stated within the IFU (instruction for use) and the BCS/ BCS XP System application sheets.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bc-thrombin-reagent-2017-10-12

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