HIGH

Beckman Coulter Mishima K.K. DxC 700 AU Recall for 142 Units Over Calibration Delay Risk (2026)

Beckman Coulter Mishima K.K. recalled 142 DxC 700 AU clinical chemistry analyzers nationwide in the United States. The recall cites a software issue that can delay test results. Labs should stop using the device and follow manufacturer instructions for service and remediation.

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

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

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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. 1. Compare your DxC 700 AU serials to B86444 or B86446 references.
  2. 2. Confirm PC setup includes Microsoft SQL Server 2022 Express.
  3. 3. Check for CAL History DB Open Error or RB History DB Open Error messages.
  4. 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.

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

  • 142 units recalled
  • DxC 700 AU
  • 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

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
B86444
B86446
14987666542545
2025060063
2025060073
+18 more
Affected States
ALL
Report Date
March 18, 2026
Recall Status
ACTIVE

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