cobas e 801 immunoassay analyzer — Class II medical device recall Z-2136-2018
Terminated recall by Roche Diagnostics Corporation, reported 2018-06-20, distributed in CA, CT, IA, IN, KY, ME, MI, NC…. The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the
| Recall number | Z-2136-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2018-04-03 |
| Classified | 2018-06-10 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2019-11-21 |
| Distributed | CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, VA |
| Quantity | 35 |
| Reason classes | packaging |
| Serial numbers | 1606-09, 1612-10, 1615-08, 1630-08, 1738-01, 1743-07, 1743-08, 1743-09, 1743-10, 1744-03, 1744-04, 1744-05, 1744-06, 1744-07, 1744-08, 1744-09, 1744-10, 1752-04, 1752-05, 1752-06, 1758-06, 1758-07, 1758-08, 1758-09, 1759-04 and 10 more |
Product
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
Reason for recall
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
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-2136-2018. 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.