—#95590

Product

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.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K081495
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Abbott Laboratories
Address: 5440 Patrick Henry Dr, Santa Clara, California 95054-1113

Distribution

Distribution pattern: Worldwide distribution: USA including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, O, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI; and countries including: Argentina, Australia, Brazil, Canada, Dominican Republic, Germany, Singapore, South Korea, St. Eustalius & St. Martin, Trinidad and Tobago.

Timeline

Recall initiated: 2010-10-15
Posted by FDA: 2011-02-10
Terminated: 2011-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95590. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.