Device recall

Z-1519-2012: Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit…

FDA device recall · Class II · Instrumentation Laboratory Co.

Key facts

Recall number (Z-number) Z-1519-2012
Recall event 61522
Product Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems
Product code GGP
Recalling firm Instrumentation Laboratory Co.
Recall class Class II
Status Terminated
Termination date Aug 24, 2012
510(k) numbers K040843
FEI number 1217183

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

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