Beckman Coulter IQ200 laboratory analyzers recalled for fluid leakage risk
What this means
The rinse-line check valve in Beckman Coulter IQ200 SPRINT, SELECT, and ELITE laboratory analyzers wears out faster than expected and needs to be replaced every year. The manufacturer did not include this replacement in the standard maintenance schedule. When the valve is not replaced annually, lamina fluid can leak inside the machine and onto the table or floor.
- If you operate one of these analyzers, contact Beckman Coulter for updated maintenance instructions and check-valve replacement guidance.
- Do not ignore fluid leaks. Clean up spills immediately to prevent slip hazards and avoid contact with the chemical fluid.
The agency's original wording
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 results.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0161-2027More Beckman Coulter recalls
- FDA-Device2026-10-21Beckman Coulter Optima ultracentrifuge rotors recalled for breakage risk
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- FDA-Device2026-10-21Beckman Coulter DxU 840m and 850m Iris analyzers recalled for lamina fluid leakage risk
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