Beckman Coulter is recalling 80 units of the DxI 9000 Access Immunoassay Analyzer because of a firmware issue in the internal circuit boards. The affected devices use firmware that can cause communication failures between sub-systems, which may lead to significant delays in reporting patient laboratory results. No injuries or incidents have been reported in connection with this issue.
Communication failures within the analyzer can prevent or delay the reporting of critical test results, potentially affecting clinical diagnosis and medical treatment decisions.
Affected units use TSI/RSI firmware version 1.1.0.0 (firmware component C29278).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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