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

• Date Initiated by Firm: September 27, 2006
• Date Posted: November 04, 2006
• Recall Status: Terminated 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: 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