—#90074

Product

Abbott brand CELL-DYN Emerald Hematology Analyzer System; List Numbers: 09H39-01; The product is manufactured in France for Abbott Diagnostics Division of Abbott Laboratories, Abbott Park, IL 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: All serial numbers.

Why it was recalled

Abbott has determined that gain settings for the non-standard specimen types may not match the gain settings for the standard specimen type. There is the potential for impact to product performance.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

The firm, Abbott, sent two "Product Correction" letters one dated March 23,2010 and a follow-up letter dated July 1, 2010, via express mail to all its consignees/customers. The letters described the product, problem and actions to be taken. The customers were instructed to perform the following steps, noted in the letter, to print and verify their gain setting. Abbott informed the customers that they would receive a mandatory software update and were instructed to install the CELL-DYN Emerald according to the attached instructions, and to complete and return the Customer Reply form via fax to 1-800-777-0051 or email to QAGCO@abbott.com. Should you have any questions or would like to discuss in more detail, contact Director Quality Assurance and Regulatory Affairs Abbott Hematology at 408-567-3403.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, and WV; and countries including: Australia, Brazil, Canada, Columbia, Dominican Republic, Germany, Puerto Rico, Singapore, South Korea, St. Eustalius & St. Martin, and Turks & Caicos.

Timeline

Recall initiated: 2010-03-23
Posted by FDA: 2011-03-18
Terminated: 2011-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90074. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.