Recall Z-1438-2017 ยท GKZ Counter, Differential Cell
Abbott Laboratories
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
| Date | Mar 9, 2017 (initiated Feb 13, 2017) |
| Status | Terminated |
| Reason | The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage |
| Root cause | Nonconforming Material/Component |
| Action | Product correction letters were sent to all affected customers on February 13, 2017 by traceable method. Letters provided information on the reason for the correction with all affected serial numbers listed. Abbott will be contacting each location to schedule replacement of the PCBA Pump Relay Board. Update: five additional serial numbers were added. Correction letters were sent to new consignees - 3 in Brazil and 2 in Mexico. |
| Quantity | 116 |
| Distribution | US and Afghanistan, Brazil, Egypt, Tanzania, Hungary, Iraq, Kenya, Netherlands, Russia, Romania Vietnam, , United Kingdom, Saudi Arabia, Philippines, Lebanon, Mexico, Japan, Jordan, India, Indonesia, Turkey, UAE, Gaza & Jericho, Germany, Bulgaria, Chile, Argentina, Luxembourg. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061667 | CELL-DYN RUBY SYSTEM Abbott Laboratories, Jul 10, 2006 |