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U.S. Department of Health and Human Services

Class 2 Device Recall cobas LiatSystem

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  Class 2 Device Recall cobas LiatSystem see related information
Date Initiated by Firm November 16, 2021
Create Date March 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-0828-2022
Recall Event ID 89643
510(K)Number K111387  
Product Classification real time Nucleic acid amplification system - Product Code OOI
Product cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Code Information UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 US Highway 202 S
Branchburg NJ 08876-3733
Manufacturer Reason
for Recall		 Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A Customer Bulletin dated 11/16/21 was sent to customers. Analyzer Return Procedure Our records indicate that you have one of the affected cobas¿ Liat¿ analyzers listed on the previous page. Because of the issue, Roche will send you a new cobas Liat analyzer. Please return your affected analyzer immediately to Roche for investigation by following the steps below: 1. A representative from the Roche Support Network Customer Support Center will contact you to initiate analyzer replacement and confirm shipping information. 2. When you receive the new cobas Liat analyzer from Roche, remove the new analyzer and FedEx shipping label from the box. 3. Place the affected analyzer in the box and seal it using packing tape. 4. Affix the FedEx postage paid shipping label to the outside of the box. 5. Take the box containing the affected analyzer to an appropriate FedEx location for return shipping at no charge to you. Actions Required " Follow the steps in the Analyzer Return Procedure section above. " File this Customer Bulletin for future reference. Please contact the Roche Support Network Customer Support Center at 1-800-800-5973 if you have questions about the information in this Customer Bulletin.
Quantity in Commerce 14 units
Distribution Worldwide distribution - US Nationwide distribution in the states of CO, IL, IN, KY, MI, NC, and TX. The countries of Cyprus, Spain, and Hong Kong.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OOI and Original Applicant = IQUUM INC
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