—#213154

Product

Beckman Coulter DxI 9000 Access Immunoassay Analyzer

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K221225
Affected lot / code info: UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below

Why it was recalled

When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

Root cause (FDA determination)

Software design

Action the firm took

Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/27/2025 via USPS first class mail. The notice explained the issue with the device, impact to the patient, and provided a workaround until a software upgrade is available. If the consignee further distributed the affected device, they were directed to provide a copy of the notice to the recipient. For questions, contact Customer Support Center, from the website: http://www.beckmancoulter.com

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2025-03-27
Posted by FDA: 2025-04-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.