Lower riskMedical device recall · FDA · Published January 7, 2020
Roche cobas infinity core calculator: Alarm flags not displayed in validation screen
Roche recalls cobas infinity core calculator modules for clinical use where alarm flags with < symbol don't display on validation screen. All software versions affected.
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
“Roche cobas infinity core calculator: Alarm flags not displayed in validation screen.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66155-roche-cobas-infinity-core-calculator-alarm-flags-not-displayed-in. Based on FDA recall #Z-1158-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1158-2020%22&limit=1).
The FDA announced on Jan. 7, 2020, that Roche Diagnostics Operations, Inc. voluntarily recalled the cobas infinity core calculator/data processing module due to a software defect. The hazard involves alarm flags with a "<" symbol not displaying on the validation screen during manual validation.
How to tell if you have it
cobas infinity core
Material No. 7154003001
All cobas infinity laboratory solution software versions
The hazard
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has 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).
How to tell if you have this one
Check if your cobas infinity core module has Material No. 7154003001. All cobas infinity laboratory software versions are affected.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify if your cobas infinity core has Material No. 7154003001.
Verify Software Version
Confirm your cobas infinity software version is affected by all versions.
Where it went and when
Where it was distributed
Distributed in 19 states.
Listed by the agency
Not listed
FDA distribution: “Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, California, Georgia, Hawaii, Illinois, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, New Jersey, New York, Oregon, South Carolina, Tennessee.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1158-2020 (January 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1158-2020 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.