Device recall

Z-1479-2022: Revogene, Catalog no. 610210. IVD test instrument

FDA device recall · Class II · Meridian Bioscience Inc

Key facts

Recall number (Z-number) Z-1479-2022
Recall event 90549
Product Revogene, Catalog no. 610210. IVD test instrument
Product code OOI
Recalling firm Meridian Bioscience Inc
Recall class Class II
Status Open, Classified
510(k) numbers K170558
FEI number 1524213

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)