—#25592

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 ****

510(k) numbers: K013899
Affected lot / code info: T3606, Exp 31 Mar 2004

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Drive, Rochester, New York 14650-0881

Distribution

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

Timeline

Recall initiated: 2002-12-18
Posted by FDA: 2003-02-21
Terminated: 2003-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #25592. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.