Device recall

Z-0950-2009: Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number…

FDA device recall · Class II · Abbott Laboratories Inc.

Key facts

Recall number (Z-number) Z-0950-2009
Recall event 48172
Product Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03, Lot Numbers: 54187M200 For use in the calibration of the Iron and Magnesium assays.
Product code JIX
Recalling firm Abbott Laboratories Inc.
Recall class Class II
Status Terminated
Termination date Jul 9, 2009
510(k) numbers K981706
FEI number 2018433

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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