ProductGuru Recalls

Official recall record

DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative deter

US FDA — Medical Devices · 2024-03-05 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Alert date
2024-03-05
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
15099590732103
Brand on record
Beckman Coulter, Inc.
Product category
Medical Device

What the authority reported

Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

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 2026-05-31.

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

Same barcode in other registries

The same EAN appears in 6 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

Other recalls from this brand

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.