Device recall

Z-1654-2008: ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device)

FDA device recall · Class II · Radiometer America Inc

Key facts

Recall number (Z-number) Z-1654-2008
Recall event 46686
Product ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device)
Product code CHL
Recalling firm Radiometer America Inc
Recall class Class II
Status Terminated
Termination date Feb 24, 2012
510(k) numbers K041874
FEI number 1523456

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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