Beckman Coulter, Inc.: Automated Urinalysis System
Recall Summary Beckman Coulter is recalling three models of automated urinalysis systems (IQ200 SPRINT, SELECT, and ELITE) because a valve component deteriorates faster than expected and needs to be replaced yearly, but this requirement was not included in the standard maintenance schedule. When the valve is not replaced annually, fluid can leak inside the machine and spill onto surfaces or floors, creating slip hazards, chemical exposure risks, and potential biohazard exposure. These machines are used in medical facilities worldwide.
- Recalling firm
- Beckman Coulter, Inc.
- Product
- IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B48999, C10683
- 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...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/efe3b550-2bb5-4165-99f3-a748605a1ef7