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U.S. Department of Health and Human Services

Class 3 Device Recall Vitros

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  Class 3 Device Recall Vitros see related information
Date Initiated by Firm March 26, 2003
Date Posted June 05, 2003
Recall Status1 Terminated 3 on November 16, 2004
Recall Number Z-0919-03
Recall Event ID 26148
510(K)Number K812028  
Product Classification Biuret (Colorimetric), Total Protein - Product Code CEK
Product Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.
Code Information All slide lots with coatings ''0292'' and ''0293''. The coating lot numbers are seen as ''xxxx-0292-xxxx'' and ''xxxx-0293-xxxx'' in the lot number.
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14650-0881
For Additional Information Contact Sherry L. Phillips
585-453-3728
Manufacturer Reason
for Recall
Slides may exhibit random, elevated imprecision of results.
FDA Determined
Cause 2
Other
Action Notification via letter dated 3/26/03 with instructions to discard product.
Quantity in Commerce 29,273 (domestic); 4,967 (international)
Distribution Nationwide and Worldwide.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = CEK and Original Applicant = EASTMAN KODAK COMPANY
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