CARTON LABEL: ''TDM Performance Verifier I''…

Date posted by the FDA

Feb. 21, 2003

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

Product

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 ****

Reason

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

Distribution pattern

Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39).

Quantity

1,338 cartons

Codes and lots

T3606, Exp 31 Mar 2004

Recall started

Dec. 18, 2002

Root cause (FDA)

Other

What the company told customers

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

Recall number

Z-0557-03

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0557-03. The agency record governs; check it and the company before acting.