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 Recall Z-0065-2010 · Posted 2009-10-19
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Recalling FirmAbbott Laboratories
Recall StatusTerminated
Product CodeGKZ
Date Initiated2009-07-16
Date Terminated2010-12-06
Product Quantity411 units
Reason for Recall
Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.
Firm Action
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.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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