Roche cobas c513 Analyzer Recall: High Pressure Solenoid Valve Quality Issue

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Recalling firmRoche Diagnostics Operations, Inc.9115 Hague Rd, N/A · Indianapolis, IN 46256-1025

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Roche is recalling cobas c513 analyzers with specific serial numbers because of a quality issue with high pressure solenoid valves. This could lead to potential malfunctions in the device.

Why it’s dangerous

The quality issue with high pressure solenoid valves could cause malfunctions in the analyzer. This might lead to inaccurate test results or device failure during operation.

Who’s affected

Users of the cobas c513 analyzer with serial numbers 1731-08 and 1722-03 are affected. Laboratory personnel who operate these analyzers are most at risk.

How to tell if you have this one

Check the serial number on your cobas c513 analyzer. Affected units have serial numbers 1731-08 or 1722-03.

Brand
Roche
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Identify the serial number on your cobas c513 analyzer to determine if it is affected.

✎ GovInfoNow

Questions people ask

What is the recall for?

Roche is recalling cobas c513 analyzers with serial numbers 1731-08 and 1722-03 due to a quality issue with high pressure solenoid valves.

How can I check if my analyzer is affected?

Check the serial number on your cobas c513 analyzer. Affected units have serial numbers 1731-08 or 1722-03.

What should I do if my analyzer is affected?

The recall record does not specify a remedy for affected units.

Take action

Contact Roche

We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2478-2019 — Roche Roche

Hello,

I own a Roche that is covered by recall Z-2478-2019 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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Where this comes from

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-2478-2019 (July 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2478-2019 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.

Roche Diagnostics Operations, Inc. recalls cobas c513 Analyzer

Recall notice