RecallRadar

FDA Device recall Z-2220-2024

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

On 2024-07-03 the FDA classified a Class II recall of CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 by Centers For Disease Control And Prevention, citing the H5b component may fail to amplify, resulting in an inconclusive result.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2220-2024
ClassificationClass II
Statusterminated
Initiated2024-04-26
Published2024-07-03
Last updated2026-09-13 11:57 UTC
CompanyCenters For Disease Control And Prevention
DistributionUS

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.

Identifiers

code_infoLot Code: Catalog # FluIVD03-11, lot 220307

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2220-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.