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.
Hazard
There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.
What You Should Do
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.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
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Products
- Brand
- Abbott Laboratories
- UPC
- All serial numbers below 7765.
Units Affected
6,353 units