Official recall record

DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513

US FDA — Medical Devices · 2026-08-12 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2026-08-12
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 15099590748654
Brand on record: Beckman Coulter, Inc.

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-11-12.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2023-04-05 · US FDA — Medical Devices
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

Other recalls from this brand

2026-09-21 · US FDA — Medical Devices
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima X
2026-09-21 · US FDA — Medical Devices
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima X
2026-08-12 · US FDA — Medical Devices
IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 7

All 39 official recall notices naming Beckman Coulter, Inc. on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.