medical Class II Updated 2018-07-18

Roche Diagnostics Corporation recalls Elecsys Vitamin D total II, Vitamin D Test System, Material

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: No specific lot codes. This issue affects users of the cobas e 801 module.
View official government recall

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