Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis
Recalled Product
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
Hazard / Issue
The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
Issued by
FDA
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