Atellica IM Homocysteine Calibrator Lots Do Not Meet Assay Specifications
Siemens Atellica IM Homocysteine Calibrator lots have calibration instability causing inaccurate test results. Affected calibrators do not meet assay reference interval specifications due to increased positive bias.
What this means for you
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: FDA Class II calibrator with calibration instability causing measurement inaccuracy. No illnesses or injuries have been reported, but inaccurate test results could lead to incorrect clinical decisions, making this a risk-of-harm product per the rubric.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling certain lots of the Atellica IM Homocysteine Calibrator (2 Pack), Siemens Material Number 10995498. The calibrators are used in clinical laboratories to calibrate diagnostic equipment that measures homocysteine levels in patient blood samples.
Certain lots of these calibrators do not meet the reference interval specifications outlined in the Instructions for Use due to calibrator instability. This instability results in increased positive bias, meaning the equipment calibrated with these lots may produce inaccurate (falsely elevated) test results for homocysteine measurement.
The affected product has been distributed worldwide, including throughout the United States and numerous countries in Europe, the Middle East, and Asia. A total of 2,212 packs (4,424 individual calibrator units) are affected, with 448 packs distributed in the US.
Laboratories currently using affected lots should contact Siemens Healthcare Diagnostics for replacement calibrators. Healthcare providers should consider recalling or validating results from testing performed with affected calibrators if clinically appropriate.
The recalled product
- Product
- Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- calibration-error
- measurement-bias
- assay-inaccuracy
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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