Device recall

Z-3278-2011: Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for…

FDA device recall · Class II · Abbott Laboratories, Inc

Key facts

Recall number (Z-number) Z-3278-2011
Recall event 59862
Product Clinical Chemistry Alkaline Phosphatase, List Number 7D55-21 & 7D55-31. Used for the quantitation of alkaline phosphatase in human serum or plasma.
Product code CJE
Recalling firm Abbott Laboratories, Inc
Recall class Class II
Status Terminated
Termination date Aug 17, 2012
510(k) numbers K981806
FEI number 1628664

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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