Siemens ADVIA Chemistry Enzyme 2 Calibrator Recalled for Positive Bias
Siemens is recalling ADVIA Chemistry Enzyme 2 Calibrators due to a positive bias of up to 41% in AST and AST_c assay results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2. The hazard involves inaccurate test results (positive bias) rather than direct physical injury or contamination, fitting the Moderate category for low-risk issues.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 314 units of the ADVIA Chemistry Enzyme 2 Calibrator, a multi-analyte mixture used for laboratory calibration. The recall affects lots 6JD079 and 6MD042, which were distributed worldwide, including in the United States, Denmark, Sweden, Norway, Great Britain, Belgium, Netherlands, Spain, Israel, Switzerland, France, Portugal, Greece, Germany, Slovenia, Czech Republic, Hong Kong, Colombia, Korea, and Australia.
The recall was initiated because Siemens confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with the affected lots. This bias may lead to inaccurate test results for these specific enzymes.
The source text does not specify instructions for consumers or healthcare facilities regarding the disposal or return of the product. The agency classification for this recall is Class III.
The recalled product
- Product
- ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 314
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 (1)
- Lots 6JD079 and 6MD042
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- HighSiemens Recalls Advia Chemistry Calibrator Due to Bilirubin Bias
FDA (Devices) · 2016-11-23
- HighSiemens Recalls ADVIA Chemistry A1c_3 Calibrators Due to Positive Bias
FDA (Devices) · 2013-09-11
- LowSiemens Enzyme 2 Calibrator Recalled for Positive Result Shifts
FDA (Devices) · 2017-02-22
- HighMedical Device Calibrator Recall for Salicylate Assay Due to Measurement Bias
FDA (Devices) · 2023-05-31
- HighSiemens ADVIA Chemistry A1c_3 Calibrator Recalled for Potential Bias
FDA (Devices) · 2014-09-24
- ModerateSiemens ADVIA Chemistry Calibrator Recalled for Calibration Errors
FDA (Devices) · 2020-07-01