Health product recall

Liquid Cardiac Control (2019-03-09)

Starting date:
March 9, 2019
Posting date:
May 17, 2019
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-69944

Last updated: 2019-05-17

Affected Products

Liquid Cardiac Control

Reason

Randox has confirmed a change in recovery with regards to NTproBNP in the Liquid Cardiac Control lots on Siemens Dimension EXL LOCI. Customers may observe a decrease in recovered concentration compared to the quoted target value in the value sheet, for this analyser only.

Affected products

Liquid Cardiac Control

Lot or serial number

4243CK
4244CK
4245CK

Model or catalog number

CQ 5051
CQ 5052
CQ 5053

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