Reported Nov 5, 2014 · Terminated

Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.

Abbott Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Laboratories, Inc · 1921 Hurd Dr · Irving, TX · 75038-4313

Is this the product you have?

  • Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Lot codes and dates
    • lots 43827UQ12
    • 43819UQ03
    • 44449UQ05
    • 44127UQ06
    • 44334UQ07
    • 43994UQ07
    • 44596UQ08
    • 44775UQ09
    • and 44930UQ11
Amount recalled
11916 units

Where it was sold

  • Nationwide

Why it was recalled

Package inserts have incorrect SmartWash parameters for Triglyceride.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 1, 2015 · Data as of Sep 19, 5:26 PM UTC

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