Sysmex America, Inc. is recalling 32 units of the PS-10 Sample Preparation System (software versions 1.5 and 1.6), which are used in laboratories to automate specimen processing for medical analysis. The recall is due to a software error that sporadically skips a probe washing step, potentially contaminating one patient's sample with material from a previous sample. One report of false test results has been received, although no patient injuries have been reported.
The omission of the probe wash step can cause "carry-over" contamination between samples. This contamination may lead to false laboratory results, potentially causing healthcare providers to make incorrect medical diagnoses or treatment decisions based on inaccurate data.
Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
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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