Recall Z-0387-05 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Ortho-Clinical Diagnostics
Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626.
| Date | Jan 8, 2005 (initiated Nov 22, 2004) |
| Status | Terminated |
| Reason | Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range. |
| Root cause | Other |
| Action | Letters dated 11/22/2004 issued to customers. End users instructed to manually modify the Reportable and/or Analyzer Ranges; dilute all samples with an initial CRP result greater than 9.0 mg/dL. Distributors instructed to destroy product in-house and to notify end-users to manually modify the Reportable and/or Analyzer Ranges. |
| Quantity | Cat. 1926740 - 20,903 boxes; Cat 8097990 - 34,877 boxes |
| Distribution | Nationwide and worldwide distribution. 70% of product was shipped to foreign consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030626 | VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 Ortho-Clinical Diagnostics, Inc., Mar 18, 2003 |