Ortho-Clinical Diagnostics is recalling approximately 9,860 Proboscis/Piston Assemblies used in several VITROS clinical chemistry and immunodiagnostic systems. These assemblies, manufactured between April and December 2022, contain a barrel component that may not meet specifications, causing testing tips to seat improperly. This defect can lead to falsely high results for Gentamicin and Valproic Acid tests or cause system delays that could impact patient care. Consumers should check if their laboratory equipment uses the affected assemblies based on the manufacturing date codes provided.
The out-of-specification barrel component causes laboratory tips to be improperly seated, which directly interferes with accurate sample measurement. This mechanism can result in falsely elevated test results for critical medications or trigger system errors that delay urgent patient diagnoses.
Manufacturer correction and investigation
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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