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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS GLU

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  Class 3 Device Recall VITROS GLU see related information
Date Initiated by Firm July 28, 2003
Date Posted September 11, 2003
Recall Status1 Terminated 3 on November 24, 2003
Recall Number Z-1224-03
Recall Event ID 27035
510(K)Number K955286  
Product Classification Glucose Oxidase, Glucose - Product Code CGA
Product Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]
Code Information All lots with an expiration date of 1 December 2004 and earlier.
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		 Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories.
FDA Determined
Cause 2		 Other
Action GLU Slides: Letters dated between 7/28/03 and 8/11/03 provide revised storage instructions. Customers using NaF/KOx blood collection tubes and have VITROS GLU slides that have been refrigerated for more than four months will receive replacement product. Those customers are instructed to continue to use the slides only until replacement product arrives. GLU DT Slides: Letters dated between 7/28/03 and 8/11/03 with the same instructions as for GLU slides.
Quantity in Commerce 487,912 boxes
Distribution Nationwide and worldwide distribution to distributors and end-users.
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 = CGA and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
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