CELL-DYN Emerald analyzer recall
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…
Why was CELL-DYN Emerald analyzer recalled?
There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers below 7765.
- 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…
- Recalling firm
- Abbott Laboratories
- 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.
- Recall date
- April 10, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)