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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products GLU DT Slides GEN 56

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  Class 2 Device Recall VITROS Chemistry Products GLU DT Slides GEN 56 see related information
Date Initiated by Firm September 27, 2006
Date Posted November 04, 2006
Recall Status1 Terminated 3 on August 03, 2012
Recall Number Z-0151-2007
Recall Event ID 36509
510(K)Number K841503  
Product Classification Glucose measurement system - Product Code CGA
Product VITROS¿ Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROS¿ Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. .
Code Information REF 153 2316
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14626-5101
For Additional Information Contact Mr. Joseph Falvo
585-453-3452
Manufacturer Reason
for Recall		 Positively biased results when using the VITROS¿ Chemistry Products GLU DT Slides GEN 56.
FDA Determined
Cause 2		 Other
Action On 9/26/06, the recalling firm notified its foreign affiliate consignees of this 'field correction', and instructed them to inform their customers who received these slides of this issue, provided them with an updated Calibration Data Module and instructed to re-calibrate these slides for continued use. On 9/27/06, all US end-use consignees were informed of this issue via Federal Express overnight letter (dated 9/27/06), and instructing them to re-calibrate these slides for continued use after they have installed the Calibration Data Module. The new CDMs were sent to all customers with VITROS DT 60/DT60 II Chemistry systems starting 9/27/06 concurrent with, but separate, from the correction letters. This includes consignees who purchased their GLU DT slides from distributors. On 9/28/06, all distributors were notified of this 'field correction', providing instructions and 'Questions & Answers' for them, and instructing them to inform their customers who received these slides of this issue. Calibration Data Modules were sent to all customers with VITROS DT 60/DT60 II Chemistry Systems.
Quantity in Commerce 93,252 boxes (25 slides per box) in total
Distribution Worldwide Distribution
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 = EASTMAN KODAK COMPANY
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