Health product recall

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

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

A. ELECSYS VITAMIN D TOTAL II

Lot or serial number

All lots.

Model or catalog number

07028148190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY

B. VITAMIN D TOTAL II

Lot or serial number

All lots.

Model or catalog number

07464215190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY