Recall Z-1553-2026— Beckman Coulter Mishima K.K.
Class II · Ongoing
Class II FDA medical device recall by Beckman Coulter Mishima K.K., initiated 2026-01-30. FDA's recall record names no specific 510(k) clearance for this event. Product: CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281. Reason: 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.
- Recalling firm
- Beckman Coulter Mishima K.K.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-01-30
- Firm location
- Sunto-Gun, N/A, Japan
Product description
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.