Siemens ADVIA Centaur Folate Test Kits Recalled for Calibration Failures
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.
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 source text explicitly mentions 'significant negative shifts in... patient results,' which indicates a risk of harm or incorrect medical decisions, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,840 units of ADVIA Centaur Folate (500 Tests) test kits, catalog number 06891541. These in vitro diagnostic products are used for the quantitative determination of folate in serum or red blood cells.
The recall was initiated because of calibration failures and/or significant negative shifts in quality control (QC) and patient results. The affected units were distributed worldwide, including in the United States, Canada, and Mexico.
Healthcare facilities and laboratories that have received these specific test kits should stop using them and contact Siemens Healthcare Diagnostics for further instructions on how to return or dispose of the product.
The recalled product
- Product
- ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 2,840
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 (3)
- 22289218
- 22297218
- 22535218
Distribution
Part of a larger recall action
This product is one of 4 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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