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 and 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. The hazard involves a risk of harm (development of vitamin D deficiency due to incorrect dosage adjustments) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Roche Diagnostics Corporation is recalling the Elecsys Vitamin D total II, Vitamin D Test System (Material number 07464215160). The recall involves 3,591 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 device is being recalled because it may give a falsely elevated result that is non-reproducible. If a patient's vitamin D level is monitored by these laboratory tests and their 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 MODULAR ANALYTICS E 170 module, cobas e 411 analyzer, and cobas e 601 and 602 modules. No specific lot codes are associated with this recall. Healthcare facilities and laboratories using these specific analyzer modules should verify their inventory and follow the instructions provided by Roche Diagnostics regarding the return or disposal of the affected test systems.
The recalled product
- Product
- Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 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
- 3,591
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 (2)
- cobas e 411 analyzer
- and cobas e 601 and 602 modules
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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