Device recall

Z-2086-2017: ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number…

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

Key facts

Recall number (Z-number) Z-2086-2017
Recall event 76992
Product ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in serum.
Product code CFP
Recalling firm Siemens Healthcare Diagnostics, Inc
Recall class Class II
Status Terminated
Termination date Apr 2, 2019
510(k) numbers K021535
FEI number 1219913

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)