Health product recall

Liquid Immunoassay Premium (2019-02-12)

Starting date:
February 12, 2019
Posting date:
March 8, 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-69236

Affected Products

Liquid Immunoassay Premium

Reason

The target value for T uptake on the Siemens IMMULITE 2000 is incorrect on the value sheet for the products listed.

The target value for this analyser is listed as 43.8%U and should be 39.4 %U.

Affected products

Liquid Immunoassay Premium

Lot or serial number

1723EC

Model or catalog number

LIA 3105

Companies
Manufacturer

Randox Laboratories Ltd.

55 Diamond Road

Crumlin, County Antrim

BT29 4QY

UNITED KINGDOM