[pending] Apo B Reagent, REF: OSR6143
Pending LLM rewrite. Source: FDA_DEVICE Z-1815-2025.
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
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
The recalled product
- Product
- Apo B Reagent, REF: OSR6143
- Manufacturer
- Beckman Coulter Ireland, 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 (1)
- Lot # 2631/UDI: 15099590010409
Distribution
Distributed nationwide across the United States.
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