DxC 700 AU, REF: B86444, B86446

Recall Insight

This FDA Devices action (record #Z-1552-2026) was formally reported on March 18, 2026, with the manufacturer initiating the action on January 30, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Beckman Coulter Mishima K.K. is listed as the recalling firm, operating out of Sunto-Gun, N/A. Federal records indicate 142 units are affected.

The documented reason for this recall is: 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 n… Distribution data in the federal record shows the product reached: 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, NH, ME, NY, OR, LA, PR, MN, IL, MD, MO, MS, OK, AR.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices and 1 involve the same firm, Beckman Coulter Mishima K.K.. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.