Device recall

Z-1734-2014: VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro…

FDA device recall · Class II · Ortho-Clinical Diagnostics

Key facts

Recall number (Z-number) Z-1734-2014
Recall event 68271
Product VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Product code JJE
Recalling firm Ortho-Clinical Diagnostics
Recall class Class II
Status Terminated
Termination date May 21, 2018
510(k) numbers K031924
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)