FDA recall, , Moderate risk
Beckman Coulter Chemistry Analyzers AU5800 and DxC 700 AU
Beckman Coulter Mishima K.K is recalling its Chemistry Analyzer Au5800 and DxC 700 Au because A delay in results may occur.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter Mishima K.K., located in Sunto-Gun, Japan, began a recall on January 30, 2026, of its Chemistry Analyzer AU5800 and DxC 700 AU. The recall was added to the FDA's Enforcement Report and classified on March 11, 2026, and in the FDA's weekly enforcement report on March 18, 2026. The recall covers 47 units of the Chemistry Analyzer AU5800 and 142 units of the DxC 700 AU, with US nationwide distribution across multiple states.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Chemistry Analyzer AU5800, REF: B96697, B96698, B23279, B23280, B23281
Reason: A delay in results may occur.
Rest of the reason
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
- UDI-DI
- 14987666543016
- 2025061442
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DxC 700 AU, REF: B86444, B86446
Reason: A delay in results may occur.
Rest of the reason
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.
- UDI-DI
- 14987666542545
- 2025060063
- 2025060073
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- 2025060075
- 2025060079
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Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Nebraska, Washington, Pennsylvania, California, Arizona, North Carolina, Texas, Nevada, Connecticut, Alabama, New Jersey, Tennessee, Montana, Idaho, Georgia, South Carolina, Ohio, Kansas, Wisconsin, Hawaii, Florida, Virginia, Michigan, New Hampshire, Maine, New York, Oregon, Louisiana, PR, Minnesota, Illinois, Maryland, Missouri, Mississippi, Oklahoma, Arkansas.
- Company
- Beckman Coulter Mishima K.K.Sunto-Gun, Japan
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98346
- Recall numbers
- Z-1552-2026 to Z-1553-2026
All recalls from Beckman Coulter Mishima K.K.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
