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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Diagnostics LDL_C

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  Class 2 Device Recall Roche Diagnostics LDL_C 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-0006-2009
Recall Event ID 48638
510(K)Number K012287  
Product Classification Low Density Lipoprotein Test System - Product Code MRR
Product Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322.

An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma.
Code Information Lot 69740501.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-428-2336
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 623
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 = MRR and Original Applicant = ROCHE DIAGNOSTICS CORP.
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