Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000… — Class II medical device recall Z-0378-2018
Terminated recall by Roche Diagnostics Corporation, reported 2018-01-24, distributed nationwide. Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cob
| Recall number | Z-0378-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2017-06-29 |
| Classified | 2018-01-16 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2020-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 2,517 |
| Reason classes | software |
| Serial numbers | 0753-22, 0756-30, 0757-07, 0761-08, 0763-04, 0763-06, 0763-09, 0801-27, 0801-28, 0801-29, 0802-01, 0817-20, 0829-17, 0829-20, 0884-01, 0884-02, 0884-03, 0884-04, 1005-29, 1008-10, 1016-05, 1017-01, 1017-06, 1021-03, 1021-05 and 475 more |
Product
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
Reason for recall
Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.
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-0378-2018. 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.