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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Acetaminophen Roche/Hitachi

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  Class 2 Device Recall Roche Acetaminophen Roche/Hitachi see related information
Date Initiated by Firm December 07, 2010
Date Posted March 16, 2011
Recall Status1 Terminated 3 on March 13, 2012
Recall Number Z-1679-2011
Recall Event ID 57513
510(K)Number K013757  
Product Classification Colorimetry, acetaminophen - Product Code LDP
Product Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporation, Indianapolis, IN.

For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers.
Code Information 11021000, 11071000 and 11070900.
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Road
Indianapolis IN 46256-1025
For Additional Information Contact betsy Cox
317-576-2000 Ext. 249
Manufacturer Reason
for Recall		 The current product labeling for Acetaminophen does not provide specific interference information for bilirubin, hemoglobin or lipemia. Additional testing has been performed to quantify the impact of these interferences at different concentrations and different levels of acetaminophen. Low serum concentrations of acetaminophen were included in the study.
FDA Determined
Cause 2		 Other
Action The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 07, 2010 to its customers. The letter described the product, problem, and action to be taken. The customers were instructed to be aware that endogenous interferents (i.e., bilirubin, hemolysis, and/or lipemia) may produce a falsely elevated value for samples containing concentrations less than 50 ug/ml of acetaminophen; complete and return the attached UMDC Faxback Form for Acetaminophen Assay via fax to 1-817-868-5343, and file this letter for future reference. The firm ask the customers to please consult with the physician or pathologist at their facility to determine specific clinical implications for their patients. The firm is also updating the product labeling to include information regarding the interference of icteric, hemolytic or lipemic samples. Please contact Roche Diagnostics Technical Support at 1-800-428-2336 if you have any questions about the information contained in this Urgent Medical Device Correction (UMDC).
Quantity in Commerce 8,668 units
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 = LDP and Original Applicant = ROCHE DIAGNOSTICS CORP.
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