Lipase Osr6x30, Uric Acid Osr6x98, And Enzymatic Creatinine Osr6x204 (2018-08-27)

Recall Summary Three enzyme-based medical test reagents — Lipase OSR6x30, Uric Acid OSR6x98, and Enzymatic Creatinine OSR6x204 — are being recalled across Canada. The products are being recalled because they are classified as medical devices that do not meet regulatory requirements. These reagents are used in laboratory testing to measure lipase, uric acid, and creatinine levels in patient samples.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-09-17

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/e6d47871-109f-4da8-8015-6e1ee3856c9b