DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

FDA device recall Z-1913-2025 · posted 2025-06-05 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

Reason for recall

A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

Action taken

An "URGENT MEDICAL DEVICE RECALL (UMDR)" notification letter dated 4/16/2025 was sent to customers. ACTION: If your laboratory has experienced the red system event and it is not resolved by initializing the analyzer, contact your Beckman Coulter representative and schedule a service visit. RESOLUTION: Beckman Coulter will release a modification for this issue. Your service representative will schedule the modification installation when it is available. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: Electronically, if you received this communication via email. Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact Customer Support Center: From our website: http://www.beckmancoulter.com

Root cause

Software design

Status

Open, Classified

Product code

JLW

Quantity affected

231 units

Distribution

Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France,

Date initiated

2025-04-23

Date posted

2025-06-05

Location

Chaska, MN

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