Recalling Firm / Manufacturer

Abbott Laboratories

Product

Abbott CELL-DYN 3000 Hematology Analyzer

Code Information

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.

Reason of Recall

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

Date Recall Initiated

May 11, 2007

Action

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. Firm Initiated recall is ongoing.

Contact

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.