Health product recall

Evidence MultiSTAT (2019-06-28)

Starting date:
June 28, 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-71995



Last updated:
2020-07-10

Affected Products

Evidence MultiSTAT

Reason

Randox have observed a possible fault on the multiSTAT systems SN: 30 to 91 and have detailed to engineers the steps taken to resolve this. ''Error 13004: error occurred reading camera temperature''. New hardware USB cable extensions and interface PCB upgrades have now been made available part No: ev1000-008.

Affected products

Evidence MultiSTAT

Lot or serial number

52180042

52180065

Model or catalog number

EV4115

Companies
Manufacturer

Randox Laboratories Ltd.

55 Diamond Road

Crumlin, County Antrim

BT29 4QY

UNITED KINGDOM