Roche Vitamin D Test System Recalled for Falsely Elevated Results
Roche Diagnostics is recalling the Elecsys Vitamin D total II test system because it may produce falsely elevated, non-reproducible results, potentially leading to incorrect vitamin D dosage adjustments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (development of vitamin D deficiency) due to incorrect test results, although no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Roche Diagnostics Corporation is recalling the Elecsys Vitamin D total II, Vitamin D Test System (Material number 07028148190). The recall involves 347 units distributed nationwide in the United States. This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma to aid in the assessment of vitamin D sufficiency in adults.
The recall was initiated because the device may give a falsely elevated result that is non-reproducible. If vitamin D levels are monitored by these laboratory tests and supplementation is adapted based on the results, a dosage reduction of vitamin D supplementation cannot be excluded. As a consequence, vitamin D deficiency may develop over time.
This issue affects users of the cobas e 801 module. No specific lot codes are identified for this recall. Users of the affected test system should contact Roche Diagnostics Corporation for further instructions regarding the recall and potential replacement or refund.
The recalled product
- 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 su
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 347
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- No specific lot codes. This issue affects users of the cobas e 801 module.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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