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Berhring Nephelometer SystemN Latex CDT Kit (Carb Deficient… — recall 63279

Health Canada — Medical Devices · Canada · 2020-04-15 · Type III

As described by Health Canada — Medical Devices: Berhring Nephelometer SystemN Latex CDT Kit (Carb Deficient Transferrin) (2020-03-05)

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Agency
Health Canada — Medical Devices
Recall identifier
63279
Date of alert
2020-04-15
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N latex CDT kit lots (49729, 49849, 49985 and 50084) in comparison to the HPLC method. All affected kit lots contain reagents from the same bulk. The issue has been internally observed during performed shelf-life monitoring after 15 months. CDT results in absolute concentrations may be influenced by the patient's transferrin levels and, therefore, results are reported as a ratio of CDT to total transferrin, called
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/berhring-nephelometer-systemn-

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