AMPLIFICATION KIT

AND IN VITRO AMPLIFICATION ASSAY FOR THE QUALITATIVE DETECTION OF NUCLEIC ACIDS DELVIRUS OF HUMAN IMMUNODEFICIENCY TYPE 1

Model: 6718663001, Affected: Lot: Y19318

Hematology and Pathology Devices

Model: 6396518001, Affected: Lots: Y15435, Y19322 and Y22447

Hematology and Pathology Devices

UDI 04015630983834, Lot Numbers: Y15435, Y19322, Y22447

Hematology and Pathology Devices

1

No

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic

UDI 04015630984749, Lot Numbers: Y19318

Hematology and Pathology Devices

1

No

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic