Recalling Firm / Manufacturer

Wako Chemicals USA, Inc

Product

NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part *** For in vitro diagnostic use

Code Information

Lot TQ087, Exp 02/29/08

Reason of Recall

Diagnostic reagent for clinical laboratory testing was incorrectly labeled

Date Recall Initiated

March 30, 2007

Action

The recalling firm notified consignees by letter 03/30/07 and advised of labeling error. Consignees were advised that they could return the product for relabeling or affix correct label enclosed with the notification. Distributors were requested to forward notification to end users. The firm subsequently notified consignees on 04/26/07 by fax that product should be returned for label correction. Firm Initiated recall is ongoing

Contact

Biomedical Products Company(BMP)
Riyadh
(01) 2650148

Source of Information

U.S. FDA

SFDA Comments

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