Siemens Vitamin D Total Assay Recalled for Plasma Sample Bias
Siemens Healthcare Diagnostics is recalling Vitamin D Total Assay kits due to a negative bias when testing plasma samples instead of serum.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (inaccurate diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Siemens ADVIA Centaur Vitamin D Total Assay (SMN 10699533, 500 test). The recall involves 37,437 kits distributed nationwide and to numerous foreign countries. All lot codes are affected.
The recall was initiated because of a change in the correlation between serum and plasma specimen tubes. Specifically, the assay exhibits a negative bias when plasma samples are used instead of serum samples. This discrepancy may result in inaccurate test results for patients whose samples are processed using plasma tubes.
Healthcare facilities and laboratories that purchased or received these kits should stop using them and contact Siemens Healthcare Diagnostics for further instructions. Consumers should not use these kits for home testing, as they are intended for professional laboratory use.
The recalled product
- Product
- Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 37,437
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)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Siemens Healthcare Diagnostics, Inc 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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