ProductGuru Recalls

Official recall record

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137

US FDA — Medical Devices · 2024-11-13 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Alert date
2024-11-13
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

The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting 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 2026-05-31.

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.