cobas Liat Analyzer, for in vitro diagnostic use.
FDA Recall Z-2543-2015 · Posted 2015-09-02
Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeOCC
Date Initiated2015-07-24
Date Terminated2015-12-23
Product Quantity5 pieces
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Distribution to the states of :TX and NC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.