Device recall

Z-0042-05: DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro…

FDA device recall · Class II · Dade Behring, Inc.

Key facts

Recall number (Z-number) Z-0042-05
Recall event 30005
Product DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Product code JPA
Recalling firm Dade Behring , Inc.
Recall class Class II
Status Terminated
Termination date May 10, 2005
510(k) numbers K011665
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)