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