Recalling Firm / Manufacturer

Abbott Diagnostic International, Ltd.

Product

TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This reagent system is composed of one bottle of Wash Solution, one bottle of Methotrexate Antibody, one bottle of Methotrexate Fluorescein Tracer and one bottle of Pretreatment Solution.

Code Information

Lot Number: 45050Q100

Reason of Recall

Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P.

Date Recall Initiated

March 20, 2007

Action

The Product Correction Letter dated 3/20/2007, was sent to all customers who received the affected lots. The Customers were instructed to: Determine if they had the lot listed in the Product Correction letter. Inspect each kit of the affected lot and discard any kits incorrectly configured. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them and retain Product Correction letter for their laboratory records. 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.