Beckman Coulter, Inc. is recalling 59 units of the Access 2 Immunoassay System Analyzers due to a mechanical defect where misaligned index wheels cause reagent carousel motion errors. This defect can lead to a non-operational system status, automatic cancellation of medical tests, and significant delays in providing patient results. The affected devices were distributed nationwide in the U.S. and several international locations. Consumers should contact the manufacturer immediately for further instructions regarding this equipment failure.
A mechanical misalignment in the reagent carousel module causes motion or QSMC errors that stop the analyzer from processing samples. This can lead to delayed medical diagnoses or treatment decisions because patient tests are cancelled or cannot be completed while the system is in a non-operational state.
System alignment and error management
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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