[pending] Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Pending LLM rewrite. Source: FDA_DEVICE Z-1821-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
The recalled product
- Product
- Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Category
- Medical Device — Devices
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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