Device recall

Z-3308-2024: DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number…

FDA device recall · Class II · FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD

Key facts

Recall number (Z-number) Z-3308-2024
Recall event 95288
Product DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
Product code QYT
Recalling firm FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Recall class Class II
Status Open, Classified
FEI number 3016652804

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)