Device recall

Z-0416-2007: ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number…

FDA device recall · Class II · Abbott Laboratories, Inc

Key facts

Recall number (Z-number) Z-0416-2007
Recall event 36996
Product ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.
Product code JJE
Recalling firm Abbott Laboratories, Inc
Recall class Class II
Status Terminated
Termination date Sep 24, 2007
510(k) numbers K983212
FEI number 1628664

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

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