Recalling Firm / Manufacturer

Pointe Scientific, Inc.

Product

Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Sold by Pointe Scientific, Inc

Code Information

All Lots beginning with 727801; exp. 4/09.

Reason of Recall

May be contaminated with microorganisms.

Date Recall Initiated

February 07, 2008

Action

Consignees were notified via recall letter, Urgent Medical Device, dated 2/7/08, to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email.

Contact

N/A

Source of Information

U.S.FDA

SFDA Comments

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