Direct Bilirubin, Total Bilirubin, Uric Acid, Triglycerides Gpo Blanketed And Enzymatic Creatinine Reagents (2019-08-14)

Recall Summary Several laboratory reagents used to measure bilirubin, uric acid, triglycerides, and creatinine levels in blood samples are being recalled across Canada. The products were recalled because they are classified as medical devices that did not meet regulatory requirements. The recall affects healthcare facilities and laboratories that use these reagents for patient testing.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2019-09-12
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/6446fdc5-f93d-44c6-a8f5-7fb59ac69aa1