VITROS Chemistry GENT Reagent REF 680 1711…

Date posted by the FDA

Sept. 1, 2005

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

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.

Reason

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.

Distribution pattern

The product was shipped nationwide and to Ortho-Clinical/J&J affiliates in Australia, Canada, Singapore, England, France, Germany, Italy and Spain.

Quantity

443 boxes

Codes and lots

01-5846, Exp. 31 May 2006; 01-6036 Exp 31 October 2006; 01-6239 Exp 31 January 2007

Recall started

July 19, 2005

Device type

Enzyme Immunoassay, Gentamicin

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-1460-05

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

Source: FDA · Medical device enforcement report, recall number Z-1460-05. The agency record governs; check it and the company before acting.