—#84354

Product

CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Division, Santa Clara, CA. Automated analyzer intended for in-vitro diagnostic use in the clinical laboratory.

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 under Product Listing Number: 09H39-01.

Why it was recalled

Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.

Root cause (FDA determination)

Software design

Action the firm took

Abbott Diagnostics issued a "Product Correction" notice dated July 16, 2009 describing the affected product. The notice was sent to all currently active users and included a customer reply form, a software update and installation instructions. For further information, contact Abbott Customer Support at 1-877-4ABBOTT. Customers outside the U.S. should 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 -- United States (AL, AR, AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV), Canada, Germany, Puerto Rico, Singapore, and South Korea.

Timeline

Recall initiated: 2009-07-16
Posted by FDA: 2009-10-19
Terminated: 2010-12-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84354. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.