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 involves a medical device with significant negative shifts in patient results, representing a risk of harm where specific injury reports are not detailed in the source text, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 3,114 units of ADVIA Centaur Folate (100 Tests) test kits, identified by SMN 10310308 and Cat No. 06367974. These in vitro diagnostic products are used for the quantitative determination of folate in serum or red blood cells.
The recall was initiated because the products experienced 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 and internationally to Canada and Mexico.
Healthcare facilities and laboratories that possess these specific test kits should stop using them and contact Siemens Healthcare Diagnostics for further instructions on the recall process.
The recalled product
- Product
- ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 3,114
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)
- 22288218
- 22296218
- 222907218
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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