FDA Device recall Z-2216-2016
cobas¿ Liat¿ Analyzer
- FDA Device
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of cobas¿ Liat¿ Analyzer by Roche Molecular Systems, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2216-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-09 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Molecular Systems |
| Distribution | NC, WA |
Product
cobas¿ Liat¿ Analyzer
Reason
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.
Identifiers
| code_info | US-IVD: M1-E-00383 & M1-E-00434 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2216-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.