CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematolo
FDA device recall Z-1438-2017 · posted 2017-03-09 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 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,
- Date initiated
- 2017-02-13
- Date posted
- 2017-03-09
- Date terminated
- 2018-03-06
- Location
- Santa Clara, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN RUBY SYSTEM (K061667) | Abbott Laboratories | 2006-07-10 |