Health product recall

Evidence MultiSTAT (2019-11-20)

Starting date:
November 20, 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-71987



Last updated: 2020-01-07

Affected Products

Evidence MultiSTAT

Reason

This notice relates to the release of software V2.1 For the multiSTAT Analyser with the following updates:

1. Inclusion of infiniplex classification.

2. Inclusion of russian as a supported language.

3. Installing new batches from > settings > software updates.

4. LIMS configuration enhancements.

5. New file naming convention for result reports.

6. PDF and CSV reports are now exported with a more consistent naming convention. 

7. Windows O/S security updates. See software release notes.

Affected products

Evidence MultiSTAT

Lot or serial number

All lots.

Model or catalog number

EV4115

Companies
Manufacturer

Randox Laboratories Ltd.

55 Diamond Road

Crumlin, County Antrim

BT29 4QY

UNITED KINGDOM