Z-2389-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2018
- Initiation Date
- April 27, 2018
- Termination Date
- May 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 347 units
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.
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.
Distribution Pattern
US Nationwide distribution.
Code Information
No specific lot codes. This issue affects users of the cobas e 801 module.