Health product recall

RX Daytona System Lipase and Lipase (LPS) (2018-02-28)

Starting date:
February 28, 2018
Posting date:
March 21, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66200

Affected products

A. RX Daytona System - Lipase
B. LIPASE (LPS)

Reason

Randox have now released further steps for contamination avoidance with the lipase assay on RX instruments. Users should refer to the instrument testing order specifically arranging chemistries so that lipase and triglycerides are the last two chemistries in the test running order.

Affected products

A. RX Daytona System - Lipase

Lot or serial number

05055273204230

Model or catalog number

LI3837

Companies
Manufacturer
Randox Laboratories Ltd.
55 Diamond Road
Crumlin, County Antrim
BT29 4QY
UNITED KINGDOM

B. LIPASE (LPS)

Lot or serial number

05055273204247
05055273209136
05055273214284

Model or catalog number

LI7979
LI8050
LI8361

Companies
Manufacturer
Randox Laboratories Ltd.
55 Diamond Road
Crumlin, County Antrim
BT29 4QY
UNITED KINGDOM