Siemens ADVIA Chemistry Calibrator Recalled for Calibration Errors
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Calibrator lots 534177 and 534179 due to observed calibration errors in Total and Direct Bilirubin assays.
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 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 II. The hazard involves calibration errors in laboratory assays, which is a quality control issue rather than a direct physical injury risk. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity recall involving low-risk contamination or labeling/quality errors.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,872 units of ADVIA Chemistry Calibrator. The recall involves lot 534177 (including sublots A, B, and C) and lot 534179. These products were distributed nationwide in the United States.
The recall was initiated because calibration errors were observed with the Total and Direct Bilirubin assays when using the affected calibrator lots. Specifically, lot 534177 was used for ADVIA Chemistry and lot 534179 for Atellica CH.
Healthcare facilities and laboratories should stop using the affected calibrator lots and contact Siemens Healthcare Diagnostics for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- ADVIA Chemistry Calibrator
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,872
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: 534177 (including sublots A
Distribution
Distributed nationwide across the United States.
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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