Z-1105-2023Class II

cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems...

Name: Z-1105-2023 cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems...
Creator: Roche Molecular Systems, Inc.
Published: 2022-12-21
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2022-12-21 / Open, Classified / root cause: design

FDA source

Roche Molecular Systems, Inc. began a recall of cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190 on 2022-12-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1105-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-21
Posted: 2023-02-07
Recalling firm: Roche Molecular Systems Inc
Product: cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
Product code: QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: On December 22, 2022, Roche posted the Urgent Medical Device Correction (UMDC) to its website (dialog.roche.com). On December 27, 2022, the firm also sent UMDC letters to affected customers. Consignees were instructed to monitor for negative influenza A results that are inconsistent with clinical presentation and/or other clinical and epidemiological information. Authorized or licensed Influenza NAATs are available for confirmation if clinically indicated for at-risk patients. Additionally, consignees are reminded to review the tests Instructions for Use, specifically the Intended Use Statements and Procedural Limitations sections, which provide guidance on how negative results should be utilized and mutations within the target regions of the tests can impact detection, respectively. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about this recall
Quantity in commerce: 9,948 OUS only
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Product codes and lots: UDI-DI 00875197006827 All in-date lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1105-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1104-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-07
Z-1105-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-07
Z-1106-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-07

Product code QLT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)