Z-1074-2019Class II

CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended...

Name: Z-1074-2019 CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended...
Creator: Abbott Laboratories
Published: 2019-02-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-02-20 / Terminated

FDA source

Abbott Laboratories began a recall of 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... on 2019-02-20. FDA classified it as Class II and gives the reason as "There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1074-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-20
Posted: 2019-03-29
Terminated: 2021-08-13
Recalling firm: Abbott Medical
Product: 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.
Product code: GKZ Counter, Differential Cell
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.
FDA root cause: Under Investigation by firm
Action: The recalling firm, Abbott, issued "Product Correction Urgent Immediate Action Required" letters dated 2/21/2019 via FedEx priority overnight express mail on 2/21/2019 to its customers. The letter described the issue, patient impact, and necessary actions. The customers were instructed to follow the necessary actions and complete and return the Customer Reply form via fax, prior to March 7, 2019 via FAX #: 18007770051 or email [email protected]. Even if you no longer have the instrument(s). If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
Quantity in commerce: 6,353 units
Distribution: 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.
Product codes and lots: All serial numbers below 7765.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1074-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1074-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-10	2019-03-29

Product code GKZ

K081495Class IICell-Dyn Emerald SystemAbbott Laboratories / cleared 2009-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)