Recall Z-0065-2010 ยท GKZ Counter, Differential Cell
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.
| Date | Oct 19, 2009 (initiated Jul 16, 2009) |
| Status | Terminated |
| Reason | Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 411 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081495 | CELL-DYN EMERALD SYSTEM Abbott Laboratories, Feb 4, 2009 |