—#40842

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.

FDA product code: LCD — Enzyme Immunoassay, Gentamicin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K042479
Affected lot / code info: 01-5846, Exp. 31 May 2006; 01-6036 Exp 31 October 2006; 01-6239 Exp 31 January 2007

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

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

Timeline

Recall initiated: 2005-07-19
Posted by FDA: 2005-09-01
Terminated: 2006-03-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40842. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.