Recall Z-2220-2024— Centers For Disease Control and Prevention

Name: FDA recall Z-2220-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-26

Class II · Terminated

Class II FDA medical device recall by Centers For Disease Control and Prevention, initiated 2024-04-26, terminated 2025-02-05. It names one FDA 510(k) clearance: K200370. Product: CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11. Reason: The H5b component may fail to amplify, resulting in an inconclusive result..

Recalling firm: Centers For Disease Control and Prevention
Classification: Class II
Status: Terminated
Initiated: 2024-04-26
Terminated: 2025-02-05
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

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 KitCenters for Disease Control and Prevention·cleared 2020-03-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

Reason for recall

The H5b component may fail to amplify, resulting in an inconclusive result.

Data sourced from openFDA. This site is unofficial and independent of the FDA.