Device recall

Z-1280-2024: Atellica IM Erythropoietin (EPO) Assay (100 Test)

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

Key facts

Recall number (Z-number) Z-1280-2024
Recall event 93939
Product Atellica IM Erythropoietin (EPO) Assay (100 Test)
Product code GGT
Recalling firm Siemens Healthcare Diagnostics, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K183088
FEI number 2432235

At a glance

  • 1–9 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)