Beckman Coulter Mishima K.K. recalled 47 AU5800 chemistry analyzers sold nationwide in the United States after a software delay can cause calibration and reagent databases to fail to open. The issue occurs when a calibration monitor using Microsoft SQL Server 2022 Express remains open for more than 15 minutes, potentially halting analysis. Healthcare facilities should stop using the devices and (a
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
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter Mishima K.K. or your healthcare provider for instructions. Notification method: Letter
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The AU5800 is a high-throughput chemistry analyzer used in clinical laboratories to perform multiple assays. It is often deployed in hospital and reference labs for timely patient diagnostics.
If the calibration monitor remains open for more than 15 minutes, databases may fail to open, causing a delay in results and potential interruption of diagnostic workflows.
This recall is not described as part of a broader industry pattern in the provided information.
Delays in test results can impact diagnosis and patient treatment timelines, particularly in high-volume labs.
Recall letters and device identifiers are available via Beckman Coulter or the FDA recall page referenced in the data.
Remedy processing may take weeks; exact timelines will be provided by Beckman Coulter after service scheduling.
Keep recall letters, model numbers, serial numbers, purchase records, and service communications in a dedicated file for compliance and audit purposes
Product: CHEMISTRY ANALYZER AU5800 Reference numbers: B96697, B96698, B23279, B23280, B23281 Sold in: United States nationwide Recall date: 2026-01-30 Manufacturer: Beckman Coulter Mishima K.K. Quantity: 47 units Price: Unknown Status: Active Notes: Distribution includes multiple states nationwide.
No injuries or incidents have been reported.
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