Device recall

Z-0803-03: Aeroset Direct HDL Reagent, LN 7D67-01

FDA device recall · Class III · Abbott Laboratories Diagnostic Div

Key facts

Recall number (Z-number) Z-0803-03
Recall event 25990
Product Aeroset Direct HDL Reagent, LN 7D67-01
Recalling firm Abbott Laboratories Diagnostic Div
Recall class Class III
Status Terminated
Termination date Sep 16, 2004
510(k) numbers K981580
FEI number 2018433

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event

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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