Siemens Atellica CH Fructosamine Test Recall for Positive Bias
Siemens is recalling Atellica CH Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management and hypoglycemia.
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 risk-of-harm product where injury (hypoglycemia) has not yet been reported, fitting the High severity criteria for potential harm without confirmed incidents.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica CH Systems Fructosamine (FRUC) test, used for the quantitative measurement of glycated protein in human serum or plasma on ADVIA Chemistry systems. The recall involves 28 units in the United States and 255 units outside the US, distributed across various states and foreign countries.
The recall is due to a potential 60 umol/L positive bias in fructosamine results compared to the predicate assay reference. This bias may lead to incorrect adjustments in hyperglycemic therapy, where more aggressive management of glycemia could contribute to hypoglycemia.
Healthcare facilities and laboratories using these tests should stop using the affected lots and contact Siemens for further instructions. Patients who have had recent fructosamine tests should consult their healthcare provider to review their results and current glucose management plans.
The recalled product
- Product
- Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 11097637
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
Distribution
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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