Lower riskMedical device recall · FDA · Published December 12, 2022
Roche cobas infinity central lab software recall: Order mismatch risk
Roche recalls specific cobas infinity central lab software versions that may mismatch patient samples due to a configuration error. Affected units must be checked for specific settings.
A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.
“Roche cobas infinity central lab software recall: Order mismatch risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59165-roche-cobas-infinity-central-lab-software-recall-order-mismatch-risk. Based on FDA recall #Z-0952-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0952-2023%22&limit=1).
The FDA announced on Dec. 12, 2022, that Roche Diagnostics Operations, Inc. is recalling cobas infinity central lab systems due to a software bug that can mismatch patient orders with incorrect sample IDs. The agency issued recall number Z-0952-2023 for the voluntary Class II recall.
How to tell if you have it
cobas infinity central lab, Material Number 07154003001
UDI-DI 04015630936007
Software versions 2.5.x, 3.01.x, 3.02.x, and 3.03.x
The hazard
A software bug in the Host Connectivity Agent can cause orders to be mismatched to another patient's sample ID if specific configuration pre-conditions are met. This occurs when the date in a sample's barcode does not match the order date sent from the Laboratory Information System.
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). Other recent recalls of similar products include GE Healthcare Enterprise Archive V8 Software Recall (July 31, 2026), GE Healthcare Centricity Enterprise Archive V2/V3/V4 Software Recall (July 31, 2026), and GE Healthcare Workflow Core Services V8 Recall (July 31, 2026).
How to tell if you have this one
Check if your cobas infinity central lab software is version 2.5.x, 3.01.x, 3.02.x, or 3.03.x and has been configured with the four specific pre-conditions listed in the recall notice.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Configuration
Verify if your cobas infinity central lab software meets the four specific configuration pre-conditions described in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide. Foreign distribution pending.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 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-0952-2023 (December 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0952-2023 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.