FDA Device recall Z-2543-2015
cobas Liat Analyzer, for in vitro diagnostic use
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of cobas Liat Analyzer, for in vitro diagnostic use by Roche Molecular Systems, citing 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 Analyze….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2543-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-24 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Molecular Systems |
| Distribution | NC, TX |
Product
cobas Liat Analyzer, for in vitro diagnostic use.
Reason
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.
Identifiers
| code_info | Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2543-2015%22
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