medical Class II Updated 2025-05-07

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

Distribution: Nationwide (United States)
Lot/Code Info: Siemens Material Number (SMN): 10736515; Udi-DI: 00809708121860; Lot Numbers: All lot numbers with prefix (xx) 02 or 12; epoc Software Version and Senor Configuration: epoc Host SW V3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
View official government recall

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