Z-0557-03

CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials Catalog Number 896 2540 Made in USA by...

Name: Z-0557-03 CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by...
Creator: Ortho-Clinical Diagnostics
Published: 2002-12-18
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2002-12-18 / Terminated / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics began a recall of 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... on 2002-12-18. The reason FDA records is "Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0557-03
Status: Terminated
Initiated: 2002-12-18
Posted: 2003-02-21
Terminated: 2003-04-14
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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 for recall: Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Letters dated 12/18/02 with instructions to inspect inventory and to discard affected product.
Quantity in commerce: 1,338 cartons
Distribution: Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39).
Product codes and lots: T3606, Exp 31 Mar 2004

K013899Class IIVitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, CalibratorsOrtho-Clinical Diagnostics / cleared 2002-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)