FDA Device

Abbott CELL-DYN 3000 Hematology Analyzer

Hazard

The product failed electrostatic discharge testing, which could result in product failure.

What You Should Do

Remedy

Mandatory Technical Service Bulletins (TSB) are being issued to Field Service to upgrade all instruments in the field. All customers will be contacted by Field Service to schedule this mandatory upgrade. The upgrades are expected to take 12 months.

Products

Abbott CELL-DYN 3000 Hematology Analyzer
Brand
Abbott Laboratories
UPC
Model number CELL-DYN 3000 CS: List Numbers 91323-01 and 91323-03, all serial numbers distributed on or before May 3, 2007. Model number CELL-DYN 3000 SL: List Numbers 91325-01 and 91325-03; all serial numbers distributed on or before May 3, 2007.

Units Affected

3,429 units, all models