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U.S. Department of Health and Human Services

Class 2 Device Recall cobas Liat Analyzer

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  Class 2 Device Recall cobas Liat Analyzer see related information
Date Initiated by Firm July 24, 2015
Date Posted September 02, 2015
Recall Status1 Terminated 3 on December 23, 2015
Recall Number Z-2543-2015
Recall Event ID 71785
510(K)Number K111387  
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OCC
Product cobas Liat Analyzer, for in vitro diagnostic use.
Code Information Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 US Highway 202 S
Branchburg NJ 08876-3733
For Additional Information Contact
800-800-5973
Manufacturer Reason
for Recall		 Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Roche sent an Urgent Medical Device Recall letter dated July 24, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Actions Required Identify the affected systems in your inventory by referencing the serial numbers in the table on page 1. You will be contacted to return affected systems for immediate replacement. Complete the attached fax form and fax it to 1-317-521-4815. File this UMDR for future reference. Please contact the Roche Support Network Customer Support Center cobas¿ Liat hotline at 1-800-800-5973, if you have questions about the information contained in this letter.
Quantity in Commerce 5 pieces
Distribution US Distribution to the states of :TX and NC.
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 = OCC and Original Applicant = IQUUM INC
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