Siemens Healthcare Diagnostics Inc. has confirmed the occurrence of discrepant high glucose results in samples with glucose results on the lower end of the reportable range (at or below 54 mg/dl) when using the above listed lots of BGEM test cards in conjunction with sensor configuration 41.1 (software version: EPOC Host v3.37.3 and EPOC NXS v4.10.6). the observed maximum bias for the affected lots are detailed in the urgent field safety notice. Recall start date: June 5, 2023
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