Device recall

Z-0721-2021: ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro…

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

Key facts

Recall number (Z-number) Z-0721-2021
Recall event 86900
Product ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)
Product code JQA
Recalling firm Siemens Healthcare Diagnostics, Inc.
Recall class Class II
Status Open, Classified
FEI number 2432235

At a glance

  • None 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)