Z-0173-06

VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester...

Name: Z-0173-06 VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester...
Creator: Ortho-Clinical Diagnostics
Published: 2005-10-12
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2005-10-12 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626 on 2005-10-12. The reason FDA records is "Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0173-06
Status: Terminated
Initiated: 2005-10-12
Posted: 2005-11-18
Terminated: 2008-09-22
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626
Product code: LEH Radioimmunoassay, Vancomycin
Reason for recall: Negatively biased results can be observed when the reagent pack has less than five tests remaining and has been on the analyzer greater than 2 days.
FDA root cause: Other
Action: Letters dated 10/12/2005 issued to end users in the U.S. Customers advised they may continue to use the VANC Reagent if their laboratory processes QC fluids according to protocol. A return reply form is included. Foreign affiliates were notified via e-mail on 10/12/2005.
Quantity in commerce: 784 boxes x 6 packs x 50 tests
Distribution: Product shipped to medical facilities (end-users) in the U.S. and to 9 International J&J affiliates in Australia, Canada, Caribbean, Chile, France, Philippines, Portugal, Taiwan, UK/Northern Europe, Israel, Saudi Arabia and Venezuela.
Product codes and lots: 01-5919, Exp. 5/31/2005 (EXPIRED): 01-6032, Exp. 9/30/2005 (EXPIRED); and 02-6284, Exp. 1/28/2006

Product code LEH

K043386Class IIVitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and Tdm Performance Verifiers I, II and IIIOrtho-Clinical Diagnostics, Inc. / cleared 2005-02-07

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)