Device recall

Z-0194-2019: Atellica CH 930 Analyzer (SMN 11067000). The Atellica" Solution is a…

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

Key facts

Recall number (Z-number) Z-0194-2019
Recall event 80774
Product Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Product code JJE
Recalling firm Siemens Healthcare Diagnostics, Inc.
Recall class Class II
Status Terminated
Termination date Aug 12, 2021
510(k) numbers K151767
FEI number 2432235

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)