Roche cobas e 601 module: Inaccurate test results due to quality issue
Roche recalls cobas e 601 modules (part 04745922001) for potential inaccurate test results from a quality issue with high pressure solenoid valves.
Lower-risk recall
Quality issue with high pressure solenoid valves may cause inaccurate results.
Contact the company
What happened, in plain English
Roche is recalling cobas e 601 modules used in their cobas 6000 Modular Series systems because a quality issue with high pressure solenoid valves may cause inaccurate test results. This affects laboratory equipment that performs medical testing. Read more at govinfonow.com/recall/67390-roche-cobas-e-601-module-inaccurate-test-results-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/67390-roche-cobas-e-601-module-inaccurate-test-results-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2476-2019
Cite this page
“Roche cobas e 601 module: Inaccurate test results due to quality issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67390-roche-cobas-e-601-module-inaccurate-test-results-due-to. Based on FDA recall #Z-2476-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2476-2019%22&limit=1).
Why it’s dangerous
The quality issue involves high pressure solenoid valves in the cobas e 601 module, which can lead to inaccurate test results. This means lab tests might give wrong outcomes, potentially affecting patient care decisions.
Who’s affected
Laboratories using Roche cobas 6000 Modular Series systems with the specific cobas e 601 module (part number 04745922001) are affected. Medical lab staff and healthcare facilities that rely on this equipment for testing are most at risk.
How to tell if you have this one
Check for the cobas e 601 module with part number 04745922001 or serial number 31A1-01 on your cobas 6000 Modular Series system. This module is used in laboratory testing equipment.
- Brand
Roche- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2476-2019 | cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001; Serial # : 31A1-01 | 1 unit |
| Z-2477-2019 | Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001; cobas c 701 module Serial # : 19P2-01, 1390-03, 1139-04, 1139-05, 1139-06. cobas c 702 module serial # : 1126-03, 1237-10, 14C2-04 cobas¿ 8000 ISE module serial # : 1943-01, 1943-02, 1943-03, 1943-04, 1943-05, 1943-06, 1943-07, 1943-08, 1943-09, 1943-10, 15B3-05. | 19 units |
| Z-2478-2019 | cobas c513 Analyzer; Serial # :1731-08, 1722-03 | 2 units |
What to do — step by step
Check Module Details
Identify the cobas e 601 module with part number 04745922001 or serial number 31A1-01 on your cobas 6000 Modular Series system.
Where it went and when
Where it was distributed
Distributed in 15 states.
FDA distribution: “State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alaska, California, Florida, Hawaii, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, Montana, New York, Ohio, Oregon, Texas.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this a safety hazard?
No, the recall is for potential inaccurate test results, not a safety hazard like fire or injury.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2476-2019 (July 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2476-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.