Device recall

Z-1816-2022: Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number…

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

Key facts

Recall number (Z-number) Z-1816-2022
Recall event 90825
Product Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
Product code JGJ
Recalling firm Siemens Healthcare Diagnostics, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K861700
FEI number 2517506

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)