FDA Class II Device Recall: Beckman Coulter DxC 700 AU
Summary
The FDA has issued a Class II recall for Beckman Coulter's DxC 700 AU device, identified as recall Z-1552-2026. The recall is ongoing due to potential delays in results caused by issues with the SQL Server 2022 Express software when open for extended periods, which can lead to database errors.
What changed
The FDA has classified a recall for Beckman Coulter's DxC 700 AU clinical chemistry analyzer as Class II, designated Z-1552-2026 and ongoing as of March 18, 2026. The issue stems from the Microsoft SQL Server 2022 Express software, which, when open for more than 15 minutes, can cause errors preventing reagent blank and calibration databases from opening. This may lead to delays in obtaining critical test results.
Healthcare providers using the DxC 700 AU device, particularly those with the specified software configuration, should be aware of this recall. While the FDA has not specified a compliance deadline, affected entities should review their system configurations and consult Beckman Coulter's advisories for remediation steps to mitigate the risk of delayed results and potential misdiagnosis. This recall impacts nationwide distribution within the US.
What to do next
- Review system configurations for DxC 700 AU devices with Microsoft SQL Server 2022 Express.
- Consult Beckman Coulter advisories for remediation steps.
- Assess potential impact of delayed results on patient care.
Source document (simplified)
Beckman Coulter Mishima K.K.
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1552-2026 · 20260318 · Ongoing
Product
DxC 700 AU, REF: B86444, B86446
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..; sy...
Distribution
US Nationwide distribution including in the states of NE, WA, PA, CA, AZ, NC, TX, NV, CT, AL, NJ, TN, MT, ID, GA, SC, OH, KS, WI, HI, FL, VA, MI, N...
Source: openFDA Enforcement API
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Healthcare alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when FDA: Device Recalls Class II publishes new changes.