Ortho-Clinical Diagnostics, Inc. has recalled 7,717 units of VITROS Chemistry Products CRP Slides (Catalog Number 1926740). These diagnostic slides are used by healthcare professionals in laboratories to measure C-reactive protein (CRP) levels in blood samples to monitor inflammation. The recall was issued because the slides may produce results that are significantly lower than the actual concentration when testing samples with very high CRP levels. Specifically, the device may report a value in the 70-90 mg/L range when the actual concentration is much higher than 90 mg/L, and there is no indication to the operator that the sample requires dilution. No incidents or injuries have been reported to date.
The biased test results could lead a physician to believe a patient's inflammation level is lower than it truly is, potentially resulting in a misdiagnosis or a delay in appropriate medical treatment. Because the device does not provide an error message or alert for these high-concentration samples, laboratory staff have no way to know that the reported result is inaccurate or that the sample needs to be diluted for re-testing.
Used for quantitatively measuring C-reactive protein (CRP) concentration in serum and plasma.
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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