cobas Liat Analyzer, for in vitro diagnostic use.
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- July 24, 2015
- Posted
- September 2, 2015
- Terminated
- December 23, 2015
- Recall Number
- Z-2543-2015
- Quantity
- 5 pieces
- Firm Location
- Branchburg, NJ
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.
Distribution
US Distribution to the states of :TX and NC.
Lot / Code Info
Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389
Root Cause
Nonconforming Material/Component
Action Taken
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.