Lower risk Medical device recall · FDA · Published October 27, 2017

Roche MRSA/SA Test Kits May Have Reduced Accuracy - Stop Using

Roche recalls certain MRSA/SA test kits due to potential reduced accuracy, risking missed infections. The US is unaffected as these tests aren't available here.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1195-2018Medical device Roche ›

Lower-risk recall

The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others. The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.

Take action

Contact the company

Recalling firmRoche Molecular Systems, Inc.1080 US Highway 202 S · Branchburg, NJ 08876-3733

✎ GovInfoNow plain-language explainer

Roche is recalling specific MRSA/SA test kits that may not work as intended, which could lead to undetected infections in patients and spread of MRSA. The US is not affected because these tests aren't available in the country. Read more at govinfonow.com/recall/72650-roche-mrsa-sa-test-kits-may-have-reduced-accuracy-stop.

Source Summary by GovInfoNow · govinfonow.com/recall/72650-roche-mrsa-sa-test-kits-may-have-reduced-accuracy-stop · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1195-2018

Cite this page

“Roche MRSA/SA Test Kits May Have Reduced Accuracy - Stop Using.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72650-roche-mrsa-sa-test-kits-may-have-reduced-accuracy-stop. Based on FDA recall #Z-1195-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1195-2018%22&limit=1).

The FDA announced on 2017-10-27 that Roche Molecular Systems, Inc. is recalling Nucleic Acid tests intended for screening for MRSA/SA due to potential decreased performance. The agency stated the United States is not impacted as the product is not available there.

How to tell if you have it

Brand: Roche
Product: cobas MRSA/SA nucleic acid test
Lot #s: 70712A, 70601W, 70713A, 70718A, and 70809A
Units affected: 136 kits

The hazard

Context

GovInfoNow's records show Roche Molecular Systems, Inc. has had 10 other recalls on record since 2018-05-02. Other recent recalls include the Roche cobas SARS-CoV-2 & Flu Assay Recall (2022-12-21), the Roche cobas 5800 PCR device recall (2022-09-08), and the Roche cobas LiatSystem recall (2021-11-16). Other recent recalls of similar products include the Roche Elecsys Anti-TSHR Assay Recall (2025-11-21), the GET TESTED 8 in 1 STI Test Kit Recall (2025-11-03), and the Immunotech Estrone RIA Kit Recall (2025-12-15).

How to tell if you have this one

Check the lot numbers: 70712A (6 kits), 70601W (76 kits), 70713A (4 kits), 70718A (50 kits). These kits were sold for in vitro diagnostic use.

Brand
Roche
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Look for lot numbers 70712A, 70601W, 70713A, or 70718A on the test kits.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

Oct 27, 2017Firm started the recall
Mar 26, 2018FDA classified it Class II
Apr 4, 2018Published in FDA’s Enforcement Report
Apr 27, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More Roche recalls

Link to this recall

<a href="https://govinfonow.com/recall/72650-roche-mrsa-sa-test-kits-may-have-reduced-accuracy-stop">Roche MRSA/SA Test Kits May Have Reduced Accuracy - Stop Using (GovInfoNow)</a>

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-1195-2018 (October 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1195-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.