FDA Device

Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; Product is distributed by Abbott Diagnostics Division, Santa Clara. CA and manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL Intended use: The CELL-DYN Emerald is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.

Hazard

There is the potential for the instrument to not power up due to the flash memory issue. This will result in an error message displayed is "No Memory Available" and has the potential for delay in generating patient results.

What You Should Do

Remedy

The firm, Abbott Laboratories, sent a "Product Correction" letter dated October 15, 2010 to all customers. The letter described the product, problem and action to be taken by the customer. The customers were instructed to install a new printer driver in the software location using the provided instructions and to complete and return the Customer Reply Form via fax 1-800-777-0051 or email to QAGCO@abbott.com even if they no longer have the instrument. If you have any questions regarding this information, U.S. customers should call Customer Support at 1-877-4ABBOTT; customers outside the U.S., please contact your local hematology customer support representative.

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Products

Abbott brand CELL-DYN Emerald, CELL-DYN Emerald CPU Board Hematology System; List Number: 09H39-01; Field Replaceable Unit (FRU) Numbers: 8701686901, 8701686902; Product is distributed by Abbott Dia
Brand
Abbott Laboratories
UPC
Serial numbers ending in  0063,0110,0196,0197,  0230,0281,0285,0293,  0319,0329,0332,0358,  0361,0362,0396,0435,  0440,0468,0474,0606,  0642, 0664, 0687, and  0719 through 1331

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