Medical Device Recall: DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Beckman Coulter, Inc. · May 22, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
183 analyzers
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2735-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.