Recall Z-0161-2027— Beckman Coulter, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2026-08-12. It names 3 FDA 510(k) clearances: K252580, K210127, K022774. 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 results..
- Recalling firm
- Beckman Coulter, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-12
- Firm location
- Miami, FL, United States
510(k) clearances named in this recall
3 on FDA's record- K252580 — iQ200 Series
- K210127 — iQ200 System, iChemVELOCITY Automated Urine Chemistry System
- K022774 — IQ 200 SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.