cobas Liat Analyzer — Class II medical device recall Z-2543-2015
Terminated recall by Roche Molecular Systems, Inc., reported 2015-09-09, distributed in NC, TX. Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED
| Recall number | Z-2543-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2015-07-24 |
| Classified | 2015-09-02 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2015-12-23 |
| Distributed | NC, TX |
| Quantity | 5 units |
| Serial numbers | M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389 |
Product
cobas Liat Analyzer, for in vitro diagnostic use.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2543-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.