cobas¿ Liat¿ Analyzer — Class II medical device recall Z-2216-2016
Terminated recall by Roche Molecular Systems, Inc., reported 2016-07-27, distributed in NC, WA. Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are
| Recall number | Z-2216-2016 |
|---|---|
| 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 | 2016-05-09 |
| Classified | 2016-07-15 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2021-03-24 |
| Distributed | NC, WA |
| Quantity | 2 |
Product
cobas¿ Liat¿ Analyzer
Reason for recall
Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
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-2216-2016. 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.