cobas Liat Analyzer, for in vitro diagnostic use.
FDA device recall Z-2543-2015 · posted 2015-09-02 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OCC
- Quantity affected
- 5 pieces
- Distribution
- US Distribution to the states of :TX and NC.
- Date initiated
- 2015-07-24
- Date posted
- 2015-09-02
- Date terminated
- 2015-12-23
- Location
- S Branchburg, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER (K111387) | Iquum, Inc. | 2011-08-04 |