Beckman Coulter, Inc.: Automated Urinalysis System

Recall Summary Beckman Coulter is recalling two automated urinalysis systems (DxU 840m Iris and DxU 850m Iris) because a check valve in the rinse line wears out faster than expected and needs to be replaced every year, but this replacement was not included in the required annual maintenance schedule. When the valve is not replaced annually, it can leak lamina fluid inside the machine, potentially spilling onto the floor or table and creating slip hazards, chemical exposure risks, and biohazard contamination. This recall affects medical facilities worldwide, including throughout the United States and numerous countries.

Recalling firm: Beckman Coulter, Inc.
Product: DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Reason: The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure), biohazardous exposure, property damage, and delayed patient...
Classification: Class I
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-08-12
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY, MA, MD, SC, WI, TX, OH, VA, PA, IL, NH, KS, GA, NC, IA, PR, TN, OR, UT, NJ, MI, CO, NM, MS, LA, RI, OK, WA, MO, ME, IN, CT, AZ, AR, MT, MN, ID, DE, AL, WV, DC, KY, NV, WY, ND, HI, AK, SD, VT, GU and...

Recall details on Nibble Recalls: https://trynibble.app/recalls/c5553dc4-2efa-4097-b471-8f15b550fc2c