Atellica IM Homocysteine Calibrator recalled for assay instability
Siemens Healthcare Diagnostics is recalling certain lots of Atellica IM Homocysteine Calibrator because calibrator instability causes increased positive bias and does not meet the assay reference interval requirements.
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: This is an FDA Class II recall. The source text does not report any illnesses, hospitalizations, or injuries; the hazard is a calibrator instability that affects test accuracy, making this a quality/performance issue rather than a direct health threat. This fits the Moderate category for labeling or performance-related recalls without reported adverse outcomes.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling certain lots of the Atellica IM Homocysteine Calibrator (2 Pack, Siemens Material Number 10995498) worldwide. The calibrators do not meet the assay Instructions for Use reference interval due to calibrator instability, which results in increased positive bias in test results.
The affected lots (86236A74 and 44206A75) were distributed both in the United States and internationally. In the US, affected packs were distributed nationwide across multiple states including California, New York, Texas, Florida, and others. Internationally, affected packs were distributed to numerous countries across Europe, the Middle East, and Asia.
Healthcare providers and laboratories using the affected calibrator lots should discontinue use and contact Siemens Healthcare Diagnostics for replacement stock or further guidance. The reference interval discrepancy could affect the accuracy of homocysteine test results.
The recalled product
- Product
- Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- calibrator-instability
- assay-accuracy
- positive-bias
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)
- (01)00630414598253(10)44206A75(17)20250925. Kit lot numbers: 86236A74
- 44206A75.
Distribution
Distributed nationwide across the United States.
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