—#27175

Product

Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.

FDA product code: CEK — Biuret (Colorimetric), Total Protein
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K812028
Affected lot / code info: All slide lots with coatings ''0292'' and ''0293''. The coating lot numbers are seen as ''xxxx-0292-xxxx'' and ''xxxx-0293-xxxx'' in the lot number.

Why it was recalled

Slides may exhibit random, elevated imprecision of results.

Root cause (FDA determination)

Other

Action the firm took

Notification via letter dated 3/26/03 with instructions to discard product.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Drive, Rochester, New York 14650-0881

Distribution

Distribution pattern: Nationwide and Worldwide.

Timeline

Recall initiated: 2003-03-26
Posted by FDA: 2003-06-05
Terminated: 2004-11-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #27175. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.