Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CHEMISTRY ANALYZER AU5800 Recalled by Beckman Coulter Mishima K.K. Due to A delay in results may occur. When clinical...

Date: January 30, 2026
Company: Beckman Coulter Mishima K.K.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter Mishima K.K. directly.

Affected Products

CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281

Quantity: 47

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Beckman Coulter Mishima K.K.

Beckman Coulter Mishima K.K. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report