Device Recall Simplexa Flu A/B and; RSV Direct assay

Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.

Immunology and Microbiology Devices

2

No

Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.

Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.