Approximately 7,450 units of the Sight OLO CBC Test Kit (Model TK1) have been recalled by Sight Diagnostics Ltd because one specific lot of cartridges was found to have bacterial contamination. This contamination can cause the device to report falsely high platelet counts, showing results that are about 7.5 k/ul higher than they actually are. This defect means the test kit is performing outside of its required accuracy specifications. Consumers and healthcare facilities should immediately identify if they have the affected lot to avoid incorrect diagnostic results.
The bacterial contamination causes a positive bias in platelet counts, which can lead to inaccurate blood test results. This could cause healthcare providers to misinterpret a patient's health status or potentially overlook conditions requiring medical intervention.
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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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