Roche cobas Integra Albumin Gen.2 test kit 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 certain albumin test kits that may have quality control issues, which could lead to inaccurate results. This affects users who rely on these tests for medical diagnosis.

Why it’s dangerous

The test kits may have low quality control recovery and invalid calibration, which could lead to inaccurate albumin measurements in blood samples. This might result in incorrect medical diagnoses if used without proper calibration.

Who’s affected

Users of Roche cobas Integra Albumin Gen.2 test kits with catalog number 05166861190 are affected. Laboratory staff and healthcare providers who use these kits for blood tests are most at risk.

How to tell if you have this one

Check for catalog number 05166861190 on the test kit. The affected lots are 33962301 and 37437301, expanded to include these lots on December 20, 2019.

Brand
Roche
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Verify the catalog number and lot number on the test kit to confirm if it is affected.

✎ GovInfoNow

Questions people ask

Why is this test kit being recalled?

The recall is due to low quality control recovery and invalid calibration, which could lead to inaccurate albumin measurements.

What lots are affected?

Lots 33962301 and 37437301 are affected, with the recall expanded on December 20, 2019.

Do I need to stop using the test kit?

No specific stop-use instruction is provided; check the kit details to confirm if it is affected.

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-0152-2020 — Roche Roche

Hello,

I own a Roche that is covered by recall Z-0152-2020 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-0152-2020 (September 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0152-2020 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 Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the

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