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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Diagnostics IRON2

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  Class 2 Device Recall Roche Diagnostics IRON2 see related information
Date Initiated by Firm June 11, 2008
Date Posted October 09, 2008
Recall Status1 Terminated 3 on September 22, 2009
Recall Number Z-0007-2009
Recall Event ID 48638
510(K)Number K951595  
Product Classification Iron (Non-Heme) Test System - Product Code JIY
Product Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03183696122.

An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of iron in serum and plasma.
Code Information Lot 60017301.
Recalling Firm/
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
Manufacturer Reason
for Recall
Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.
FDA Determined
Cause 2
Labeling Change Control
Action Consignees were notified via an Urgent Medical Device correction letter dated 6/11/08 informing users of the problem and providing them with work-around instructions. The instructions suggests 1) inserting the cassette rack slowly; 2) using mainly reagent slots A, B, or C; 3) tilting the rack slightly clockwise so the barcode scanner does not read the barcode at an exact 90 degree angle; and 4) confirming the rack is properly seated on the track and displayed on the Cassette Status screen. If the cassette barcode does not register after following the Work-Around instructions, then customers are required to contact Diagnostics Technical Support.
Quantity in Commerce 523
Distribution Nationwide 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 = JIY and Original Applicant = ROCHE DIAGNOSTIC SYSTEMS, INC.