Device recall

Z-2484-2020: VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product…

FDA device recall · Class II · Ortho Clinical Diagnostics

Key facts

Recall number (Z-number) Z-2484-2020
Recall event 85762
Product VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Product code JJE
Recalling firm Ortho Clinical Diagnostics
Recall class Class II
Status Terminated
Termination date Nov 16, 2022
510(k) numbers K083173
FEI number 1000136573

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)