Official recall record

DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

US FDA — Medical Devices · 2023-09-12 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-09-12
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 firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.

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.

2024-11-13 · US FDA — Medical Devices
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
2025-04-23 · US FDA — Medical Devices
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
2025-09-19 · US FDA — Medical Devices
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
2024-03-05 · US FDA — Medical Devices
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative,
2024-01-03 · US FDA — Medical Devices
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

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

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.