Z-0387-05

Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90...

Name: Z-0387-05 Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90...
Creator: Ortho-Clinical Diagnostics
Published: 2004-11-22
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2004-11-22 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics... on 2004-11-22. The reason FDA records is "Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0387-05
Status: Terminated
Initiated: 2004-11-22
Posted: 2005-01-08
Terminated: 2005-05-02
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: DCK C-Reactive Protein, Antigen, Antiserum, And Control
Reason for recall: Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.
FDA 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 in commerce: Cat. 1926740 - 20,903 boxes; Cat 8097990 - 34,877 boxes
Distribution: Nationwide and worldwide distribution. 70% of product was shipped to foreign consignees.
Product codes and lots: Coatings 401 thru 419.

Product code DCK

K030626Class IIVitros Chemistry Products Crp Slide and Calibrator Kit 7Ortho-Clinical Diagnostics, Inc. / cleared 2003-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)