Roche Diagnostics Corporation recalls Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended fo…

Recall date

April 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2389-2018

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

US Nationwide distribution.

Why it was recalled

The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the immunoassay analyzer.