Z-2498-2021Class II

cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

Name: Z-2498-2021 cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Creator: Roche Molecular Systems, Inc.
Published: 2021-08-04
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2021-08-04 / Terminated

FDA source

Roche Molecular Systems, Inc. began a recall of cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190 on 2021-08-04. FDA classified it as Class II and gives the reason as "Customers have reported an increased number of false positive SARS-CoV-2 results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2498-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-04
Posted: 2021-09-21
Terminated: 2024-02-23
Recalling firm: Roche Molecular Systems Inc
Product: cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Product code: QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Reason for recall: Customers have reported an increased number of false positive SARS-CoV-2 results.
FDA root cause: Under Investigation by firm
Action: On August 4, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were instructed to take the following actions: - Immediately discontinue the use of the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat system, lot number 10119Z. - For handling previous positive results generated with the cobas SARS-CoV-2 & Influenza A/B test for use on the cobas Liat system, follow your laboratory s standard operating procedures to investigate the potential for false positive results. Please consult with the physician or clinicians at your facility to determine specific clinical implications for your patients. - Repeat testing can be performed using other cobas SARS-CoV-2 & Influenza A/B lot numbers. - Complete all sections of the enclosed faxback form and fax it to 1-888-312-5960 or email it to [email protected]. - Discard lot number 10119Z according to your local waste management ordinance. - File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-800-5973 if you have questions about this recall.
Quantity in commerce: 211 kits (US); 3073 kits (OUS)
Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.
Product codes and lots: Lot 10119Z

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2498-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2498-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-21

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)