FDAApril 27, 2018device

Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 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. ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnosticsroche

UPCs

07464215160

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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