cobas 8000 analyzer series Operators Manual Roche cobas Filter label:… — Class II medical device recall Z-1792-2014
Terminated recall by Roche Diagnostics Operations, Inc., reported 2014-06-25, distributed nationwide. Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant res
| Recall number | Z-1792-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2014-05-21 |
| Classified | 2014-06-13 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2015-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 149 |
Product
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
Reason for recall
Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
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-1792-2014. 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.