FDA scrutiny grows across devices, diagnostics, and consumer products

Recent safety items include Class I corrections involving glucose-meter patient-result assignment and a radioimmunoassay product, plus a separate Class I recall limited to four lots of Werfen’s HemosIL AcuStar HIT-IgG test over false-negative risk. One serious injury was reported in the glucose-meter correction; verify official notices and instructions. Philips’ proposed DOJ resolution over its 2021 sleep/respiratory-device recall remains preliminary, with final terms unresolved.