Health product recall

Evidence Investigator Analyzer (2018-11-10)

Starting date:
November 10, 2018
Posting date:
April 12, 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-69562



Last updated: 2019-04-12

Affected Products

Evidence Investigator Analyzer

Reason

The software has been modified to allow for enhanced detection of reference and correction DTRs (discrete test regions).

Affected products

Evidence Investigator Analyzer

Lot or serial number

E1-11165

Model or catalog number

EV3602

Companies
Manufacturer

Randox Laboratories Ltd.

55 Diamond Road

Crumlin, County Antrim

BT29 4QY

UNITED KINGDOM