Siemens ADVIA Chemistry A1c_3 Calibrator Recalled for Potential Bias
Siemens is recalling ADVIA Chemistry A1c_3 Calibrators because they may cause a percent bias in HbA1c test 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential diagnostic errors.
Plain-English summary
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry A1c_3 Calibrators (REF/Catalog Number 10491408) used on ADVIA Chemistry Systems. The recall involves 1,122 kits distributed in the United States and 236 kits distributed internationally. The affected lots are 3HD044 (exp. 11/01/2015) and 3LD068 (exp. 01/01/2016).
The recall is due to a potential percent bias of -9% to +11% in hemoglobin (Hb)A1c samples when using these specific calibrator lots. This bias is a percentage of the HbA1c result, not absolute HbA1c units. Depending on quality control limits, this issue may not have been detected by the laboratory.
The product is intended for in vitro diagnostic use in the calibration of A1c_3 and Total Hemoglobin_3 methods on automated clinical chemistry analyzers. The recall covers distribution in the USA and internationally to numerous countries including Argentina, Austria, Brazil, Canada, China, and others. Users should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions.
The recalled product
- Product
- ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total…
- Manufacturer
- Siemens Healthcare Diagnostics
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 (2)
- Lots 3HD044 (exp. 11/01/2015)
- and 3LD068 (exp. 01/01/2016)
Distribution
Distributed nationwide across the United States.
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