Beckman Coulter Inc. has recalled approximately 1,805 units of its REMISOL Advance software due to a defect that can misidentify patients as newborns. This occurs when a patient's date of birth is missing or set to January 1, 1900, causing the system to apply the wrong clinical reference ranges to laboratory test results. While the laboratory test values themselves remain accurate, the software may fail to flag abnormal results correctly or may auto-validate incorrect interpretations for upload to hospital records. No injuries or incidents have been reported.
The software may use incorrect reference ranges for patients, leading to erroneous interpretations of lab results that could affect clinical decisions. Because results are auto-validated and uploaded to laboratory information systems, a provider might receive results flagged as "normal" that are actually abnormal for an adult patient.
Quantity affected: 1,805 systems.
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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