Device recall

Z-0792-2007: ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x…

FDA device recall · Class II · Abbott Laboratories, Inc

Key facts

Recall number (Z-number) Z-0792-2007
Recall event 37780
Product ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits), 07K60-25 (100 test kits)and 07K60-30 (4 x 500 test kits); manufactured by Abbott Ireland Diagnostic Division, Lisnamuck, Longford, Ireland.
Product code CGN
Recalling firm Abbott Laboratories, Inc
Recall class Class II
Status Terminated
Termination date Sep 25, 2007
FEI number 1628664

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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