CLASS II Device recall · Reported 30 Oct 2019 · FDA Enforcement Report

Emerald Diluent Tubing, List number 09H50 recalled

Abbott Laboratories is recalling Emerald Diluent Tubing, List number 09H50-01, accompanying Cell-dyn Emerald instrument, distributed in 7 states. The recall was initiated on 9 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTubing 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.

Quantity recalled22 analyzers with tubing

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0173-2020
FDA event ID: 83793
Recalling firm: Abbott Laboratories, Santa Clara, CA
Classification: Class II
Status: Terminated
Recall initiated: 9 May 2019
FDA classified: 22 Oct 2019
Reported: 30 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 May 2019	Recall initiated by company
22 Oct 2019	Classified by FDA	+166 days
30 Oct 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Georgia Louisiana Massachusetts North Carolina New York South Carolina Texas

Questions about this recall

Why was it 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.

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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