[pending] DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520
Pending LLM rewrite. Source: FDA_DEVICE Z-1672-2025.
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 reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
The recalled product
- Product
- DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that meas
- Manufacturer
- Beckman Coulter Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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