Official recall record

DxI 9000 Access Immunoassay Analyzer, Part Number C11137

US FDA — Medical Devices · 2025-09-19 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2025-09-19
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 has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

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
2023-09-12 · US FDA — Medical Devices
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
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

2026-03-16 · US FDA — Medical Devices
Access Total T4 Calibrator, Catalog No. 33805
2025-11-26 · US FDA — Medical Devices
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
2025-11-26 · US FDA — Medical Devices
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin S

All 32 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.