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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 LiatSystemsee related information
Date Initiated by FirmNovember 16, 2021
Create DateMarch 28, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0828-2022
Recall Event ID 89643
510(K)NumberK111387 
Product Classification real time Nucleic acid amplification system - Product Code OOI
Productcobas 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
FEI Number 2243471
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
ActionA 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 Commerce14 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = OOI
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