Health product recall

SLDL (2019-11-13)

Starting date:
November 13, 2019
Posting date:
January 6, 2020
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-71983



Last updated:
2020-07-10

Affected Products

SLDL

Reason

The Randox kit insert for SLDL 562616 has now been updated. As part of this update the normal range patient data from the multi-ethnic study of atherosclerosis (MESA) has calculated the 75th percentile cut-off value for chd to be 50mg/dl detailed in the reference interval section.

Affected products

SLDL

Lot or serial number

472277

Model or catalog number

562616

Companies
Manufacturer

Randox Laboratories Ltd.

55 Diamond Road

Crumlin, County Antrim

BT29 4QY

UNITED KINGDOM