Siemens Healthcare Diagnostics Inc, FSN-ACHC 22-07, Atellica CH Lithium_2 (LITH_2); Atellica CH Lithium (Li) | Siemens Healthcare Diagnostics Inc. has confirmed customer complaints indicating the potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. Preliminary investigation has indicated that this issue may be due to foam formation in the reagent packs resulting in inconsistent reagent delivery. The observation of falsely elevated results is random in nature and only impacts the LITH_2 and Li reagents. See Tables 2 and 3 below for the observed worst case results. | | |