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.
Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
Roche is recalling certain Cobas 8000 and Cobas PRO Interface Modules that may cause delayed sample tube processing. This could lead to inaccurate lab results if the system is used without proper maintenance.
The firmware in the Interface Module may cause sample tubes to process slower than intended. This delay could result in inaccurate laboratory test results if the system is not properly maintained or monitored.
Laboratory users with the specific hardware and firmware versions listed in the recall. Those handling medical samples are most at risk of inaccurate test results.
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.
Review the firmware version on your device to see if it is COBASa_2.2.0 or COBASa_2.3.0.
Confirm your serial number starts with FLX.0208 (US) or FLX.0116 through FLX.049 (other regions).
The recalled firmware versions are COBASa_2.2.0 and COBASa_2.3.0.
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.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0560-2024 — Roche Roche Hello, I own a Roche that is covered by recall Z-0560-2024 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
