CLASS II Device recall · Reported 10 Apr 2019 · FDA Enforcement Report

Cell-dyn Emerald analyzer recalled by Abbott Laboratories

Abbott Laboratories is recalling Cell-dyn Emerald analyzer, distributed nationwide in the US. The recall was initiated on 20 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers below 7765.

Quantity recalled6,353 units

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-1074-2019
FDA event ID: 82240
Recalling firm: Abbott Laboratories, Santa Clara, CA
Classification: Class II
Status: Terminated
Recall initiated: 20 Feb 2019
FDA classified: 29 Mar 2019
Reported: 10 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

20 Feb 2019	Recall initiated by company
29 Mar 2019	Classified by FDA	+37 days
10 Apr 2019	Published in enforcement report	+12 days

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

Reason for recall

There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.

Product as listed by the FDA

CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.

Where it was distributed

Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Guinea, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania, Mexico, Moldova, Montenegro, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, St. Maarten, St. Vincent & The Grenadines, Sudan, Switzerland, Taiwan, Tanzania, Thailand, Togo, Trinidad & Tobago, Turkey, Turks & Caicos, UAE, Uganda, UK, Uruguay, Venezuela, Viet Nam, Yemen, Zambia, and Zimbabwe.

Nationwide Puerto Rico

Questions about this recall

Is Cell-dyn Emerald analyzer recalled?

Yes. Abbott Laboratories recalled Cell-dyn Emerald analyzer on 20 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-1074-2019.

Why was it recalled?

There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.

Which lots are affected?

All serial numbers below 7765.

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 21 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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