Reported Oct 30, 2019 · Terminated

Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm…

Abbott Laboratories

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 · 4551 Great America Pkwy · Santa Clara, CA · 95054-1208

Is this the product you have?

  • Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
Lot codes and dates
    • Tubing lot #2018-10-16
    • Instrument serial numbers 007689
    • 007690
    • 007691
    • 007692
    • 007705
    • 007706
    • 007707
    • 007708
    • 007709
    • 007728
    • 007694
    • 007695
    • 007697
    • 007766
    • 007767
    • 007768
    • 007765
    • 007710
    • 007699
    • 007700
    • 007701
    • and 007703
Amount recalled
22 analyzers with tubing

Where it was sold

Why it was recalled

The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.

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 Oct 7, 2020 · Data as of Sep 19, 7:01 PM UTC

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