Recall Z-0173-2020 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.
| Date | May 9, 2019 |
| Status | Terminated |
| Reason | The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued letters on 5/9/2019 to the consignees who had the installed instruments with the affected serial numbers. The letters were issued via FedEx priority overnight express. |
| Quantity | 22 analyzers with tubing |
| Distribution | Distribution was made to GA, LA, MA, NC, NY, SC, and TX. There was no military/government distribution. Foreign distribution was made to Australia, Germany, Greece, Honduras, Indonesia, Italy, and Serbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081495 | CELL-DYN EMERALD SYSTEM Abbott Laboratories, Feb 4, 2009 |