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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Ortho-Clinical Diagnostics
Lot Codes / Batch Numbers
Coatings 401 thru 419.
Products Sold
Coatings 401 thru 419.
Ortho-Clinical Diagnostics is recalling Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 co due to Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026