Device recall

Z-1305-04: Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.

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

Key facts

Recall number (Z-number) Z-1305-04
Recall event 29345
Product Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
Product code KFF
Recalling firm Dade Behring , Inc.
Recall class Class II
Status Terminated
Termination date Jan 6, 2005
FEI number 2517506

At a glance

  • None 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

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