Health product recall

Liquid Cardiac Controls Troponin T (2018-10-04)

Starting date:
October 4, 2018
Posting date:
October 26, 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-68096

Affected products

Liquid Cardiac Controls Troponin T

Reason

Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on the 08 June 2018. We have now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 AND CQ5053 are no longer suitable for the control of the troponin T assay due to unacceptable variation between vial.

Affected products

Liquid Cardiac Controls Troponin T

Lot or serial number
  • 4244CK
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