Health product recall

Trace Elements Normal Range Serum Control (2019-11-22)

Starting date:
November 22, 2019
Posting date:
December 13, 2019
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-71869

Last updated: 2019-12-13

Affected Products

Trace Elements Normal Range Serum Control

Reason

Incorrect value on the product IFU for the analyte of Manganese. The value was mistyped as a value of 2.69 and range of 2.29 - 3.09 on the IFU, when it was reported as 0.48 and 0.41 - 0.55 respectively.

Affected products

Trace Elements Normal Range Serum Control

Lot or serial number

C2540

Model or catalog number

66816

Companies
Manufacturer
UTAK LABORATORIES INC.
25020 AVENUE TIBBITTS
VALENCIA
91355
California
UNITED STATES