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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmNovember 22, 2004
Date PostedJanuary 08, 2005
Recall Status1 Terminated 3 on May 02, 2005
Recall NumberZ-0387-05
Recall Event ID 30570
510(K)NumberK030626 
Product Classification C-Reactive Protein, Antigen, Antiserum, And Control - Product Code DCK
ProductVitros 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.
Code Information Coatings 401 thru 419.
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactSherry L. Phillips
585-453-3728
Manufacturer Reason
for Recall		Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.
FDA Determined
Cause 2		Other
ActionLetters 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 CommerceCat. 1926740 - 20,903 boxes; Cat 8097990 - 34,877 boxes
DistributionNationwide and worldwide distribution. 70% of product was shipped to foreign consignees.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DCK
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