Roche Cobas c Bilirubin Total Gen.3 Recall: Low Quality Control Risk

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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 c Bilirubin Total Gen.3 test kits that may have low quality control recovery and invalid calibration. This could lead to inaccurate bilirubin test results, which is important for medical diagnosis.

Why it’s dangerous

The test kits may have issues with quality control recovery and calibration, which can cause inaccurate bilirubin measurements. This could lead to incorrect medical decisions if results are used for diagnosis or treatment.

Who’s affected

Healthcare providers using Roche Cobas c Bilirubin Total Gen.3 test kits for bilirubin testing in adults and neonates are affected. Patients receiving inaccurate test results due to faulty kits may be at risk.

How to tell if you have this one

Check for catalog number 05795419190 on the test kit. The lot number 36133801 is also associated with this recall.

Brand
Roche
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Look for catalog number 05795419190 and lot number 36133801 on the test kit packaging.

✎ GovInfoNow

Questions people ask

Is there a fix for the Cobas c Bilirubin Total Gen.3 test kits?

The recall notice does not specify a remedy for this issue.

How can I tell if my test kit is affected?

Check for catalog number 05795419190 and lot number 36133801 on the test kit packaging.

What is the risk of using these test kits?

The kits may have low quality control recovery and invalid calibration, which could lead to inaccurate bilirubin test results.

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-0153-2020 — Roche Roche

Hello,

I own a Roche that is covered by recall Z-0153-2020 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-0153-2020 (September 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0153-2020 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 c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative

Lower-risk recall