Lower riskMedical device recall · FDA · Published December 21, 2022
Roche cobas SARS-CoV-2 & Flu A/B tests may give false negatives; stop using
Roche recalls cobas SARS-CoV-2 and Influenza A/B tests that may produce false negative results, causing unnecessary testing and delays in treatment. Affected tests were sold with specific model numbers and lot dates.
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
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Contact the company
📍Recalling firmRoche Molecular Systems, Inc.1080 Us Highway 202 S · Branchburg, NJ 08876-3733
✎ GovInfoNow plain-language explainer
Roche is recalling certain SARS-CoV-2 and Influenza A/B tests that can give false negative results. This may lead to extra testing, psychological stress, and delays in getting proper treatment for flu. Read more at govinfonow.com/recall/59079-roche-cobas-sars-cov-2-flu-a-b-tests-may.
“Roche cobas SARS-CoV-2 & Flu A/B tests may give false negatives; stop using.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59079-roche-cobas-sars-cov-2-flu-a-b-tests-may. Based on FDA recall #Z-1105-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1105-2023%22&limit=1).
Roche Molecular Systems, Inc. voluntarily recalled cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test material on Dec. 21, 2022, according to the FDA. The recall addresses potential false negative Influenza A results that may cause delays in targeted therapy.
How to tell if you have it
Brand: Roche
Product: cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems
Material Number: 09446125190
UDI-DI: 00875197006827
Status: All in-date lots
The hazard
The firm received customer complaints regarding false negative Influenza A results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
Context
GovInfoNow's records show Roche Molecular Systems, Inc. has 10 other recalls on record since Oct. 27, 2017. Other recent recalls of similar products include Roche cobas 5800 PCR device recall (Sept. 8, 2022), Roche cobas LiatSystem recall (Nov. 16, 2021), and Roche cobas EGFR Mutation Test v2 recall (Sept. 3, 2021). Additional recent recalls include Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), Roche cobas pro integrated solutions recall (Jan. 20, 2026), and Abbott i-STAT Cartridges recall (April 1, 2026).
How to tell if you have this one
Check for the material number 09446125190 on the test kit. The tests were sold with specific lot dates and were used on cobas 5800/6800/8800 systems.
Brand
Roche
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Recall number
Product, codes & lots
Quantity
Z-1104-2023
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190; UDI-DI 00875197006674 All in-date lots
18,071 kits (US); 30,085 kits (OUS)
Z-1105-2023
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190; UDI-DI 00875197006827 All in-date lots
9,948 OUS only
Z-1106-2023
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190; UDI-DI 00875197006773 All in-date lots
727 kits OUS only
Based on the official FDA remedy
What to do — step by step
Check Test Kit
Look for the material number 09446125190 on the test kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide. Foreign distribution worldwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1105-2023 (December 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1105-2023 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.