—#36135

Product

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.

FDA product code: DCK — C-Reactive Protein, Antigen, Antiserum, And Control
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K030626
Affected lot / code info: Coatings 401 thru 419.

Why it was recalled

Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and worldwide distribution. 70% of product was shipped to foreign consignees.

Timeline

Recall initiated: 2004-11-22
Posted by FDA: 2005-01-08
Terminated: 2005-05-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36135. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.