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Recall Observatory FDA recall evidence

Device product

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.

Z-0173-2020

May 09, 2019

Class II

Product summary

Firm
Abbott Laboratories
Event
Event 83793
Status
Terminated
Classification
Class II
Quantity
22 analyzers with tubing
Official record key
device-enforcement:Z-0173-2020

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: Distribution was made to GA, LA, MA, NC, NY, SC, and TX. There was no military/government distribution. Foreign distribution was made to Australia, Germany, Greece, Honduras, Indonesia, Italy, and Serbia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.