# FDA recall Z-1552-2026

> **Beckman Coulter Mishima K.K.** · Class II · device recall initiated 2026-01-30.

## 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..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.

## 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, NH, ME, NY, OR, LA, PR, MN, IL, MD, MO, MS, OK, AR.

## Key facts

- **Recall number:** Z-1552-2026
- **Recalling firm:** Beckman Coulter Mishima K.K.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-30
- **Report date:** 2026-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunto-Gun, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1552-2026

## Citation

> AI Analytics. FDA recall Z-1552-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1552-2026. Source: US FDA. Licensed CC0.

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