Vitros CRP (C-Reactive Protein) Slides…

Date posted by the FDA

Jan. 8, 2005

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

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.

Reason

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

Distribution pattern

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

Quantity

Cat. 1926740 - 20,903 boxes; Cat 8097990 - 34,877 boxes

Codes and lots

Coatings 401 thru 419.

Recall started

Nov. 22, 2004

Device type

C-Reactive Protein, Antigen, Antiserum, And Control

Root cause (FDA)

Other

What the company told customers

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.

Recall number

Z-0387-05

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0387-05. The agency record governs; check it and the company before acting.