Advanced Instruments, LLC is recalling 58 units of the OsmoPRO MAX Automated Osmometer, a clinical diagnostic device used to measure the concentration of serum, plasma, and urine samples. The recall was initiated because system error messages can delay the testing of patient samples, and the device may require frequent, unplanned calibrations when control results fall outside the expected range. This issue affects software version 1.5.0.0 and specific serial numbers ending in 'A' that were distributed worldwide. If you use this device, you should contact the manufacturer for technical guidance on how to proceed with testing and calibration.
Software errors and inconsistent control results can lead to significant delays in critical patient diagnostic testing. If clinical results are delayed or inaccurate due to calibration issues, it could potentially impact patient care decisions.
Manufacturer Technical Support
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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