Recall Z-2389-2018 ยท MRG System, Test, Vitamin D
Roche Diagnostics Corporation
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.
| Date | Apr 27, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | On April 27, 2018, the firm issued an Urgent Medical Device Correction letter to all affected customers. The letter advised customers in the following workaround to improve sample quality prior to measurement with the Elecsys Vitamin D total II assay. The firm stated these steps are to be carried out temporarily until further information is provided: 1. Perform a thorough inspection of your pre-analytical handling to ensure a correct assay performance of Elecsys Vitamin D total II and to comply with the individual specifications of the primary tube manufacturers for all tubes in use (centrifu |
| Quantity | 347 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 Roche Diagnostics, Feb 8, 2017 |