Health product recall

Urinalysis Control Level 2 (2019-07-25)

Starting date:
July 25, 2019
Posting date:
August 9, 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-70659

Last updated: 2019-08-09

Affected Products

Urinalysis Control Level 2

Reason

Randox is re-assigning the analyte range for leukocytes for use with the Siemens Multistix method to negative to 3+. Updated value sheets are now available on www.randox.com under support and documentation. No other lots or products are affected by this issue.

Affected products

Urinalysis Control Level 2

Lot or serial number

1020UC

Model or catalog number

UC5034

Companies
Manufacturer

Randox Laboratories Ltd.

55 Diamond Road

Crumlin, County Antrim

BT29 4QY

UNITED KINGDOM