DRG International, Inc. has recalled 10 units of the DRG:HYBRiD-XL Insulin assay (Model HYE-5361) because the device may fail to calibrate correctly or the control tests may fall outside of required specifications. These failures can lead to significant delays in generating patient test results. No injuries or incidents have been reported in connection with this issue.
Failure to calibrate the instrument or pass control checks prevents the device from providing insulin measurement results. This can cause delays in clinical diagnosis and patient treatment decisions.
UDI listed in data: (01)04048474053616(17)20251130(10)429K084-1
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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