Recall Z-0919-03 ยท CEK Biuret (Colorimetric), Total Protein
Ortho-Clinical Diagnostics
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.
| Date | Jun 5, 2003 (initiated Mar 26, 2003) |
| Status | Terminated |
| Reason | Slides may exhibit random, elevated imprecision of results. |
| Root cause | Other |
| Action | Notification via letter dated 3/26/03 with instructions to discard product. |
| Quantity | 29,273 (domestic); 4,967 (international) |
| Distribution | Nationwide and Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K812028 | KODAK EKTACHEM CLIN. CHEM. SLIDES (TP) Eastman Kodak Company, Aug 3, 1981 |