Elecsys Vitamin D total II (2018-04-25)

Starting date:

April 25, 2018

Posting date:

May 18, 2018

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-66780

• Reason
• Affected products

Affected products

A. ELECSYS VITAMIN D TOTAL II
B. VITAMIN D TOTAL II

Reason

During the implementation of the Elecsys Vitamin D total Gen. II Assay, Customers reported non-reproducible, false high results. These discrepant results were observed during assay validation of Elecsys Vitamin D total II where samples were run in duplicate and, during method comparisons with Elecsys Vitamin D total. The issue manifests as follows: The first result is elevated, either above the upper end of the measuring range (>100 ng/ml or >250 nmol/ml) or within the measuring range, and repeats are significantly lower.

Affected products