Roche recalls Cobas 8000 and Cobas PRO Interface Modules with firmware versions COBASa_2.2.0 and COBASa_2.3.0 due to potential delayed sample tube processing. Affected units include specific hardware and serial numbers.
“Roche Cobas 8000 Interface Module Recall: Delayed Sample Processing Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56953-roche-cobas-8000-interface-module-recall-delayed-sample-processing-risk. Based on FDA recall #Z-0560-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0560-2024%22&limit=1).
Inpeco S.A. recalled Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM) IVD FlexLab Automation Systems due to firmware issues that may delay sample tube processing, the FDA said on Nov. 3, 2023.
How to tell if you have it
Brand: Roche
Product: Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System
Distribution: Worldwide; US Nationwide distribution in the state of MA and the countries of AUSTRIA, BELGIUM, DENMARK, ITALY, NORWAY, SPAIN
The hazard
The firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing, according to the FDA.
Context
GovInfoNow's records show Inpeco S.A. has 13 other recalls on record since Feb. 13, 2018. 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 Baxter VOLARA System Recall (Aug. 3, 2026).
How to tell if you have this one
Check for hardware version FLX-247-00 and firmware versions COBASa_2.2.0 or COBASa_2.3.0. Serial numbers starting with FLX.0208 (US) or FLX.0116 through FLX.049 (other regions) are affected.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Firmware Version
Review the firmware version on your device to see if it is COBASa_2.2.0 or COBASa_2.3.0.
Verify Serial Number
Confirm your serial number starts with FLX.0208 (US) or FLX.0116 through FLX.049 (other regions).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the state of MA and the countries of AUSTRIA, BELGIUM, DENMARK, ITALY, NORWAY, SPAIN.” 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 54 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-0560-2024 (November 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0560-2024 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.