Siemens ADVIA Fructosamine Test Recalled for Positive Bias
Siemens is recalling ADVIA Chemistry Systems-Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management.
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 (medical device) where injury (hypoglycemia) has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Systems-Fructosamine (FRUC) tests, which are used for in vitro diagnostic measurement of glycated protein in human serum or plasma. The recall involves 23 units in the United States and 204 units outside the US. The affected product is identified by Siemens Material Number 10361941.
The recall is issued because fructosamine quality control and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to the predicate assay reference. This bias could lead to a potential adjustment of hyperglycemic therapy. Positively biased results may prompt changes in glucose management that affect glycemia, and in extreme situations, more aggressive management could contribute to hypoglycemia.
The affected units were distributed in California, Delaware, Maryland, North Carolina, New Jersey, New York, and Pennsylvania, as well as in various foreign countries including Argentina, Australia, Brazil, Canada, and others. Users of the affected tests should contact Siemens Healthcare Diagnostics, Inc. for further instructions on how to proceed.
The recalled product
- Product
- ADVIA Chemistry 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): 10361941
- 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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