FDA Medical Device Recalls (openFDA)
Abbott Laboratories: 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.
- Recall number
- Z-1074-2019
- Recalling firm
- Abbott Laboratories
- 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.
- Status
- Terminated
- Initiated
- 2019-02-20
- Posted
- not on file
- Terminated
- 2021-08-13
- Reason
- There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
- 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 QAGCO@abbott.com. 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
- 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.
- Lot, serial or model codes
- All serial numbers below 7765.
- 510(k) numbers
- ["K081495"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2919069
- Firm city
- Santa Clara
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28