Roche recalls all BenchMark ULTRA Advanced Staining System units due to potential fluid leaks causing electrical shorts, heat, smoke, and fire risks. Affected units may need repair or replacement.
Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
Roche is recalling all BenchMark ULTRA Advanced Staining Systems because fluid leaks inside the device can cause electrical shorts, leading to heat, smoke, and potential fire. This hazard affects laboratory equipment used in medical testing.
Fluid leaks inside the instrument can cause electrical shorts in the power socket. This leads to heat buildup, smoke, and eventually burning or melting of the electrical cord connector and socket, creating a fire hazard.
Laboratory technicians and medical facilities using the BenchMark ULTRA Advanced Staining System are most at risk. The recall applies to all units produced with the specified material number.
Check for the material number 05342716001 on the BenchMark ULTRA Advanced Staining System. All units are affected, so no specific model or purchase date is needed.
Inspect the instrument for signs of fluid leaks, which could indicate the hazard.
Reach out to Roche Diagnostics Operations, Inc. for guidance on next steps.
Yes, all BenchMark ULTRA Advanced Staining Systems with material number 05342716001 are affected.
Check the material number 05342716001 on the device; all units are affected.
No, but you should check for leaks and contact Roche for further instructions.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0085-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0085-2021 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.
