FDA Device

VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.

Hazard

Potential for positively biased results in QC and patient samples.

What You Should Do

Remedy

Letters dated 3/15/2005 sent First Class Mail. Customers are advised product will be replaced. The letter includes modified quality control procedures that will pre-qualify each reagent pack.

Products

VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
Brand
Ortho-Clinical Diagnostics
UPC
Lot 710, Exp. 7/28/05

Units Affected

Domestic - 1359; International - 840