Centers for Disease Control and Prevention

Code	Device name	Class	Specialty	Clearances	Most recent
OZE	—	—	—	4	2025-07-11
PBK	Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set	Class II	Microbiology	3	2022-08-30
SGA	Biothreat Microbial Agent Nucleic Acid Detection Test	Class II	Immunology	2	2026-03-30

Date	Severity	Status	Recall #	Product	Code	Reason
2024-04-26	Class II	Terminated	Z-2220-2024	CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11	—	The H5b component may fail to amplify, resulting in an inconclusive result.

Date	K-number	Device	Code	Class	Specialty
2026-03-30	K260812	Francisella tularensis Real-time PCR Assay	SGA	Class II	Immunology
2025-09-30	K252072	Francisella tularensis Real-time PCR assay	SGA	Class II	Immunology
2025-07-11	K243274	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)	OZE	—	—
2025-03-14	K243931	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)	OZE	—	—
2024-05-21	K241110	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)	OZE	—	—
2022-08-30	K222558	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set	PBK	Class II	Microbiology
2022-06-24	K221834	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set	PBK	Class II	Microbiology
2022-06-10	K221658	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set	PBK	Class II	Microbiology
2020-03-10	K200370	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit	OZE	—	—

Clearance cadence by quarter