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 Recall Z-0387-05 · Posted 2005-01-08
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Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeDCK
Date Initiated2004-11-22
Date Terminated2005-05-02
Product QuantityCat. 1926740 - 20,903 boxes; Cat 8097990 - 34,877 boxes
Reason for Recall
Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and worldwide distribution. 70% of product was shipped to foreign consignees.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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