Lower riskMedical device recall · FDA · Published December 8, 2020
Roche Chemistry Analyzers May Give Incorrect Results Due to Configuration Settings
Roche recalls specific chemistry analyzers that may produce incorrect test results if configuration settings are changed, affecting clinical testing accuracy.
Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
“Roche Chemistry Analyzers May Give Incorrect Results Due to Configuration Settings.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63713-roche-chemistry-analyzers-may-give-incorrect-results-due-to-configuration. Based on FDA recall #Z-0755-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0755-2021%22&limit=1).
The FDA announced on Dec. 8, 2020, that Roche Diagnostics Operations, Inc. is recalling seven Roche cobas pro integrated solutions chemistry analyzers due to potential configuration errors causing incorrect test results. Owners should contact the company for remedy details.
How to tell if you have it
Brand: Roche
Product: Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units)
Part Number: 05641446001
Serial Numbers: 1925-10; 1931-04; 1931-05; 1931-07; 1937-10; 1938-01; 1942-10
Quantity: 7 units
The hazard
The recall cites a potential for changed configuration settings on the cobas 8000 modular analyzer series and cobas pro integrated solutions, which may cause incorrect results in several affected parameters. In cases of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has had 32 other recalls on record since July 2, 2019. Other recent recalls of similar products include Roche cobas pro integrated solutions recall (Jan. 20, 2026), Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and Roche cobas HCYS Assay Recall (Oct. 17, 2024). Other recent recalls of similar products include Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit (June 26, 2026) and AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient Results (Aug. 3, 2026).
How to tell if you have this one
Check for the product names: cobas pro ISE, cobas c 503, or cobas e 801. The serial numbers listed (1925-10, 1931-04, etc.) indicate affected units.
Brand
Roche
Category
Medical device
FDA recall event · 2 products
All 2 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.
Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001; Serial Numbers: 1925-10; 1931-04; 1931-05;1931-07;1937-10; 1938-01; 1942-10
7 units
Based on the official FDA remedy
What to do — step by step
Check Configuration Settings
Verify that the analyzers are set to the correct configuration settings as per Roche's guidelines.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 29 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0755-2021 (December 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0755-2021 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.