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.
Reported: April 10, 2019 Initiated: February 20, 2019 #Z-1074-2019
Product Description
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.
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.
Details
- Recalling Firm
- Abbott Laboratories
- Units Affected
- 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.
- Location
- Santa Clara, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Laboratories. Units affected: 6,353 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2019. Severity: Moderate. Recall number: Z-1074-2019.
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