Health product recall

Human Assayed Control Level 2 (2019-05-22)

Starting date:
May 22, 2019
Posting date:
June 7, 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-70131



Last updated: 2019-06-07

Affected Products

Human Assayed Control Level 2

Reason

Randox has revised the control ranges for ALT, bicarbonate and gamma-GT in lots 1306UN, 1308UN and 1309UN. The method name for transferrin has also been corrected to state immunoturbidimetric.

Affected products

Human Assayed Control Level 2

Lot or serial number

1306UN

1308UN

1309UN

Model or catalog number

HN1530

Companies
Manufacturer

Randox Laboratories Ltd.

55 Diamond Road

Crumlin, County Antrim

BT29 4QY

UNITED KINGDOM