Z-1460-05

VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc...

Name: Z-1460-05 VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc...
Creator: Ortho-Clinical Diagnostics
Published: 2005-07-19
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2005-07-19 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs... on 2005-07-19. The reason FDA records is "Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1460-05
Status: Terminated
Initiated: 2005-07-19
Posted: 2005-09-01
Terminated: 2006-03-13
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests.
Product code: LCD Enzyme Immunoassay, Gentamicin
Reason for recall: Negatively biased results can be observed when the reagent pack has less than 12 tests remaining and has been on the analyzer greater than 24 hours.
FDA root cause: Other
Action: Letters dated 7/19/2005 with instructions to process QC fluid according to the IFU when processing patient samples. When replacement product arrives, instructions are to destroy the remaining inventory of the recalled lots.
Quantity in commerce: 443 boxes
Distribution: The product was shipped nationwide and to Ortho-Clinical/J&J affiliates in Australia, Canada, Singapore, England, France, Germany, Italy and Spain.
Product codes and lots: 01-5846, Exp. 31 May 2006; 01-6036 Exp 31 October 2006; 01-6239 Exp 31 January 2007

Product code LCD

K042479Class IIVitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products Calibrator Kits 11, 13 & 14; Vitros CheOrtho-Clinical Diagnostics, Inc. / cleared 2005-01-06

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)