Date Initiated by Firm |
July 28, 2003 |
Date Posted |
September 11, 2003 |
Recall Status1 |
Terminated 3 on November 24, 2003 |
Recall Number |
Z-1225-03 |
Recall Event ID |
27035 |
510(K)Number |
K841503
|
Product Classification |
Glucose Oxidase, Glucose - Product Code CGA
|
Product |
Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. , 100 Indigo Creek Dr., Rochester, NY 14626. [NOTE: product has a 24-month shelf life.] |
Code Information |
All lots with an expiration date of 1June 2005 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.
|
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 |
210,050 boxes |
Distribution |
Nationwide and worldwide distribution to distributors and end-users. |
Total Product Life Cycle |
TPLC Device Report
|
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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 = EASTMAN KODAK COMPANY
|