This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
RX Daytona System - Lipase
- Starting date:
- July 25, 2016
- Posting date:
- March 10, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-62446
Reason
Reagent probe carryover has been observed from triglycerides and direct LDL (low density lipoprotein) reagents to lipase reagent on the RX Daytona, RX Daytona+ and RX Imola Analysers causing elevated lipase test results. It occurs when the lipase is tested directly before or after triglycerides or direct LDL in the test running order. It is also possible that this may occur on other instrumentation.
Affected products
RX Daytona System - Lipase
Lot or serial number
Not applicable
Model or catalog number
- LI3837
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM