Quick Facts at a Glance
- Recall Date
- January 30, 2026
- Hazard Level
- HIGH
- Brand
- Beckman Coulter
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Beckman Coulter
- Product type
- Chemistry Analyzer
- Model numbers
- B96697, B96698, B23279, B23280, B23281
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 30, 2026
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Delays in test results can impact diagnosis and patient treatment timelines, particularly in high-volume labs.
Practical Guidance
How to identify if yours is affected
- Check if your AU5800 units have references B96697, B96698, B23279, B23280, B23281
- Review recall letters from Beckman Coulter
- Verify SQL Server 2022 Express is not left open for extended periods on calibration PCs
Where to find product info
Recall letters and device identifiers are available via Beckman Coulter or the FDA recall page referenced in the data.
What timeline to expect
Remedy processing may take weeks; exact timelines will be provided by Beckman Coulter after service scheduling.
If the manufacturer is unresponsive
- Document all communications with Beckman Coulter
- Escalate to hospital risk management or regional medical device supervisory body if vendor is unresponsive
- Consider consulting with the FDA for guidance on unresponsive recalls
How to prevent similar issues
- Verify calibration software updates are installed as directed by Beckman Coulter
- Monitor calibration PC usage to ensure no long open sessions
- Maintain an online log of device status and recall communications
Documentation advice
Keep recall letters, model numbers, serial numbers, purchase records, and service communications in a dedicated file for compliance and audit purposes
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Calibration delay could halt patient testing
- Software remedy required by service professionals
- FDA and CPSR-regulated medical device recall
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.