Abbott Laboratories CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Division, Santa Clara, CA. Automated analyzer intended for in-vitro diagnostic use in the clinical laboratory. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Division, Santa Clara, CA. Automated analyzer intended for in-vitro diagnostic use in the clinical laboratory.
Brand
Abbott Laboratories
Lot Codes / Batch Numbers
All Serial Numbers under Product Listing Number: 09H39-01.
Products Sold
All Serial Numbers under Product Listing Number: 09H39-01.
Abbott Laboratories is recalling CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Divi due to Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.
Recommended Action
Per FDA guidance
Abbott Diagnostics issued a "Product Correction" notice dated July 16, 2009 describing the affected product. The notice was sent to all currently active users and included a customer reply form, a software update and installation instructions. For further information, contact Abbott Customer Support at 1-877-4ABBOTT. Customers outside the U.S. should contact your local hematology customer support representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026