Beckman Coulter Mishima K.K. is recalling 16,342 sample probes used in AU480 and AU680 clinical chemistry analyzers due to a manufacturing defect. The rounded tips of these probes prevent a necessary air layer from forming, which causes patient samples to mix with cleaning water and become diluted. This dilution results in the analyzer reporting patient test results that are lower than they actually are, which may not be detected by routine quality control checks. This recall affects probes with lot numbers ranging from 178713114 to 179433670. No injuries or incidents have been reported at this time.
Defective probes can cause reported test results to be up to 34% lower than actual values. These inaccurate results could lead to delayed diagnosis or incorrect medical treatment for patients.
Quantity: 10,176 units.
Quantity: 6,166 units.
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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