[pending] CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Pending LLM rewrite. Source: FDA_DEVICE Z-1553-2026.
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
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment
The recalled product
- Product
- CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
- Manufacturer
- Beckman Coulter Mishima K.K.
- 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 (20)
- 2025061446
- 2025061452
- 2025061454
- 2025061464
- 2025071479
- 2025071488
- 2025081513
- 2025081516
- 2025091536
- 2025091538
- 2025091543
- 2025091559
- 2025091561
- 2025111598
- 2025111602
- 2025111604
- 2025111605
- 2025111606
- 2025121618
- 2025121622
Distribution
Distributed nationwide across the United States.
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