—#38389

Product

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

FDA product code: KLI — Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K964721
Affected lot / code info: Lot 710, Exp. 7/28/05

Why it was recalled

Potential for positively biased results in QC and patient samples.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution. Product shipped worldwide via J&J foreign affiliates.

Timeline

Recall initiated: 2005-03-15
Posted by FDA: 2005-06-21
Terminated: 2006-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38389. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.