Recall Z-1074-2019 ยท GKZ Counter, Differential Cell
Abbott Laboratories
CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.
| Date | Feb 20, 2019 |
| Status | Terminated |
| Reason | There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm, Abbott, issued "Product Correction Urgent Immediate Action Required" letters dated 2/21/2019 via FedEx priority overnight express mail on 2/21/2019 to its customers. The letter described the issue, patient impact, and necessary actions. The customers were instructed to follow the necessary actions and complete and return the Customer Reply form via fax, prior to March 7, 2019 via FAX #: 18007770051 or email QAGCO@abbott.com. Even if you no longer have the instrument(s). If you or any of the health care providers you serve have any questions regarding this information, U |
| Quantity | 6,353 units |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Co |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081495 | CELL-DYN EMERALD SYSTEM Abbott Laboratories, Feb 4, 2009 |