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.
What this means for you
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.
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