Quick Facts at a Glance
- Recall Date
- January 30, 2026
- Hazard Level
- HIGH
- Brand
- Beckman Coulter Mishima K.K.
- 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 Mishima K.K.
- Product type
- Clinical Chemistry Analyzer
- Model numbers
- B86444, B86446, 14987666542545, 2025060063, 2025060073, 2025060074, 2025060075, 2025060079 +15 more
- 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
DxC 700 AU is a clinical chemistry analyzer used in laboratories to perform chemical assays. It processes patient samples and generates test results for clinical decision-making.
Why This Is Dangerous
The issue arises when a calibration monitor PC with SQL Server 2022 Express remains open for more than 15 minutes. It can trigger database open errors and cause the instrument to stop analyzing, delaying results.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Laboratories may experience delays in test results, potentially affecting patient diagnosis and treatment timelines. Service visits are required to implement a software solution, with variable timelines.
Practical Guidance
How to identify if yours is affected
- 1. Compare your DxC 700 AU serials to B86444 or B86446 references.
- 2. Confirm PC setup includes Microsoft SQL Server 2022 Express.
- 3. Check for CAL History DB Open Error or RB History DB Open Error messages.
- 4. If affected, halt use and contact the manufacturer for remediation instructions.
Where to find product info
Recall notification letter from Beckman Coulter Mishima K.K. and FDA enforcement page Z-1552-2026.
What timeline to expect
Remediation requires on-site service to apply a software solution. Timelines vary by institution.
If the manufacturer is unresponsive
- Document all contact attempts
- Escalate to the hospital's risk management or purchasing contact
- Consult FDA recall resources if the manufacturer is slow to respond
How to prevent similar issues
- Verify software compatibility before deployment.
- Establish a recall monitoring process for laboratory IT integrations.
- Keep all recall communications on file and ensure staff are trained on immediate stop-use procedures.
- Consider alternative devices only after confirming remediation,
Documentation advice
Archive recall letter, serial numbers, affected instrument IDs, service reports, and all correspondence with the manufacturer.
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Product Details
DxC 700 AU, REF: B86444, B86446. Quantity: 142. Distribution: United States nationwide, including NE, WA, PA, CA, AZ, NC, TX, NV, CT, AL, NJ, TN, MT, ID, GA, SC, OH, KS, WI, HI, FL, VA, MI, NH, ME, NY, OR, LA, PR, MN, IL, MD, MO, MS, OK, AR.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- REF: B86444, B86446
- MS SQL Server 2022 Express installed on PC
- open > 15 minutes triggers DB open errors
- Reagent Blank and CAL History DB Open Error conditions
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