Recalling Firm / Manufacturer

Abbott Laboratories

Product

Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Laboratories, Abbott Park, IL (the syringe is packaged in a white box and sealed with a label wrapped around the center of the box-The main analyzer list number is 08H00-01, )

Code Information

Package Dates (printed on syringe label); 08 May 2007 to 25 June 2007

Reason of Recall

Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter

Date Recall Initiated

July 25, 2007

Action

This Recall was initiated 07/24/07 via a Product Recall letter-Immediate Action Required-instructing users to discontinue use and destroy any units under recall. Replacements may be obtained by contacting the local Customer Support Center at 1-877-4Abbott.

Contact

Source of Information

U.S. FDA

SFDA Comments

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