Roche recalls cobas e 601 modules (part 04745922001) for potential inaccurate test results from a quality issue with high pressure solenoid valves.
Quality issue with high pressure solenoid valves may cause inaccurate results.
Roche is recalling cobas e 601 modules used in their cobas 6000 Modular Series systems because a quality issue with high pressure solenoid valves may cause inaccurate test results. This affects laboratory equipment that performs medical testing.
The quality issue involves high pressure solenoid valves in the cobas e 601 module, which can lead to inaccurate test results. This means lab tests might give wrong outcomes, potentially affecting patient care decisions.
Laboratories using Roche cobas 6000 Modular Series systems with the specific cobas e 601 module (part number 04745922001) are affected. Medical lab staff and healthcare facilities that rely on this equipment for testing are most at risk.
Check for the cobas e 601 module with part number 04745922001 or serial number 31A1-01 on your cobas 6000 Modular Series system. This module is used in laboratory testing equipment.
Identify the cobas e 601 module with part number 04745922001 or serial number 31A1-01 on your cobas 6000 Modular Series system.
Roche recalls the cobas e 601 module due to a quality issue with high pressure solenoid valves that may cause inaccurate test results.
The recall record does not specify a remedy, so no action is required beyond checking if your module matches the part number or serial number.
No, the recall is for potential inaccurate test results, not a safety hazard like fire or injury.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2476-2019 — Roche Roche Hello, I own a Roche that is covered by recall Z-2476-2019 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.
