Device recall

Z-0488-2007: ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated…

FDA device recall · Class II · Abbott Laboratories MPG

Key facts

Recall number (Z-number) Z-0488-2007
Recall event 36889
Product ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 tests), and 6C25-30 (4 x 500 tests); Abbott Laboratories, Abbott Park, IL 60064-3500
Product code CEP
Recalling firm Abbott Laboratories MPG
Recall class Class II
Status Terminated
Termination date Dec 9, 2009
FEI number 1415939

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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