FDA Device

CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****

Hazard

Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.

What You Should Do

Remedy

Letters dated 12/18/02 with instructions to inspect inventory and to discard affected product.

Products

CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
Brand
Ortho-Clinical Diagnostics
UPC
T3606, Exp 31 Mar 2004

Units Affected

1,338 cartons