—#208485

Product

DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Software versions 1.17.0 or below, UDI-DI 15099590732103.

Why it was recalled

When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.

Root cause (FDA determination)

Software design

Action the firm took

The recalling firm issued letters dated 5/16/2024 on 5/22/2024 via postal mail and email notification. The letter described the issue, impact, action, and resolution. Beckman Coulter will implement the correction with a future software release and the consignee will be contacted by their Beckman Coulter service representative to schedule the software upgrade. If the device has been forwarded to another laboratory, the consignee is requested to provide a copy of the letter to that location. A response was requested within 10 days electronically via email or through completion and return of the enclosed Response Form.

Recalling firm

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

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, TX, and WA. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom of Great Britain and Northern Ireland.

Timeline

Recall initiated: 2024-05-22
Posted by FDA: 2024-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208485. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.