Device recall

Z-0830-2020: Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red…

FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc

Key facts

Recall number (Z-number) Z-0830-2020
Recall event 84078
Product Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Product code CGN
Recalling firm Siemens Healthcare Diagnostics, Inc
Recall class Class II
Status Terminated
Termination date Feb 14, 2025
510(k) numbers K010050
FEI number 1219913

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)