Roche Diagnostics Corporation: Medical Device Recall in 2018 - (Recall #: Z-2389-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 27, 2018

Date Posted: July 18, 2018

Recall Number: Z-2389-2018

Event ID: 80008

Reason for Recall:

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.

Status: Terminated

Product Quantity: 347 units

Code Information:

No specific lot codes. This issue affects users of the cobas e 801 module.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated