Summary
The selected portfolio has documented FDA clearances for TRUE METRIX and TRUE METRIX GO glucose monitoring systems and TRUEdraw lancing devices. K140100 is a legacy Nipro Diagnostics record linked to current TRUE METRIX products by FDA recall records; clearance scope is specific to the reviewed device versions. [2][4][3][1]
FDAβs April 28, 2026 safety communication, updated May 19, addresses E-5 error-code risks across affected TRUE METRIX, AIR, GO and PRO systems, including co-branded products. FDA recommends transition to an alternative testing method when possible, without stopping glucose testing before an alternative is available. Consult the FDA communication for the full recommendations. [14]
At this review, Trividiaβs product page reports corrected meter software and revised instructions distinguishing E-5 from EHi. This manufacturer update does not establish that all affected units have been corrected or that FDA has terminated the recall. [17]
The scoped records also include an open 2025 Good Neighbor Pharmacy meter recall for display defects and a terminated 2020 meter-packaging event. An older TRUEread strip event remains recorded as open in the retrieved FDA feed, but its mapping to the current portfolio is unresolved and it is excluded from current-portfolio counts. [11][9][7][5]