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.
- Company
- Abbott Laboratories
- Recall Initiated
- July 16, 2009
- Posted
- October 19, 2009
- Terminated
- December 6, 2010
- Recall Number
- Z-0065-2010
- Quantity
- 411 units
- Firm Location
- Santa Clara, CA
Reason for Recall
Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.
Distribution
Worldwide Distribution -- United States (AL, AR, AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV), Canada, Germany, Puerto Rico, Singapore, and South Korea.
Lot / Code Info
All Serial Numbers under Product Listing Number: 09H39-01.
Root Cause
Software design
Action Taken
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.