Z-1413-2021Class II

cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on...

Name: Z-1413-2021 cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on...
Creator: Roche Molecular Systems, Inc.
Published: 2021-03-25
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2021-03-25 / Open, Classified

FDA source

Roche Molecular Systems, Inc. began a recall of cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190 on 2021-03-25. FDA classified it as Class II and gives the reason as "Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1413-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-25
Posted: 2021-04-13
Recalling firm: Roche Molecular Systems Inc
Product: cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
FDA root cause: Unknown/Undetermined by firm
Action: Roche issued Urgent Medical Device Correction letter on March 25, 2021. Letter states reason for recall, health risk and action to take: Actions Required " Inform any operators that use the cobas Liat analyzer and/or cobas SARS-CoV-2 & Influenza A/B test of the potential hazards associated with this issue and provide a copy of this UMDC as appropriate. " If you observe an increase in Influenza B positive results that does not match community infection rates, stop testing on the cobas Liat analyzer and contact the Roche Support Network Customer Support Center at 1-800-800-5973 to determine if a tube leak or other issue has occurred. " If you observe dual- and/or triple-positive results for a particular sample, retest the sample with the cobas SARS-CoV-2 & Influenza A/B test for use with the cobas Liat analyzer using a different cobas Liat analyzer. If you do not have an additional analyzer or if results on the second analyzer disagree with the results from the first analyzer, stop testing on the affected analyzer and contact the Roche Support Network Customer Support Center at 1-800-800-5973. " Monitor your invalid result rates. If there is a sudden increase or if invalid results are observed repeatedly on a specific cobas Liat analyzer, stop testing on the analyzer and contact the Roche Support Network Customer Support Center at 1-800-800-5973. " If the Thermal runaway (disable) message appears (as described later in this UMDC) on your cobas Liat analyzer running software version 3.3.0, stop testing on the analyzer and contact the Roche Support Network Customer Support Center at 1-800-800-5973. " For handling previous positive results generated with the cobas SARS-CoV-2 & Influenza A/B test for use on the cobas Liat analyzer, follow your laboratorys standard operating procedures to investigate the potential for false positive results. " Complete all sections of the enclosed faxback form (TP-01256) and fax it to 1-866-503-1216 or email it to roche6136@ster
Quantity in commerce: US: 143,823 kits Ex-US: 57,219 kits
Distribution: Nationwide WorldWide
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1413-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1413-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-12
Z-1414-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-12

Product code QJR

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)