FDA Device recall Z-0499-2018
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (d…
- FDA Device
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (d… by Roche Diagnostics, citing A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0499-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-05 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | US |
Product
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Reason
A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
Identifiers
| code_info | none |
|---|
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-0499-2018%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.