# FDA recall Z-2730-2017

> **Beckman Coulter Inc** · Class II · device recall initiated 2017-05-15.

## Product

Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288    Product Usage:  Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.

## Reason for recall

The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with AQUA Cal 1.

## Distribution

US Nationwide Distribution in the states of AL, AR, AK, CA, CO, DE, FL, GA, ID, IL, IN, IO, KS, KY, LA, MA, MD, MS, MI, ME, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WV, WI, and Puerto Rico  Brunei, Canada, China, Czech Republic, France, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, Panama, Paraguay, Philippines, Qatar, South Africa, Taiwan, Thailand, Turkey, United Arab Emirates, & United Kingdom.

## Key facts

- **Recall number:** Z-2730-2017
- **Recalling firm:** Beckman Coulter Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-15
- **Report date:** 2017-07-19
- **Termination date:** 2020-09-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2730-2017

## Citation

> AI Analytics. FDA recall Z-2730-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2730-2017. Source: US FDA. Licensed CC0.

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