Z-1195-2018Class II

Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic

Name: Z-1195-2018 Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic
Creator: Roche Molecular Systems, Inc.
Published: 2017-10-27
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2017-10-27 / Terminated / root cause: software

FDA source

Roche Molecular Systems, Inc. began a recall of Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic on 2017-10-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1195-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-27
Posted: 2018-03-26
Terminated: 2020-04-27
Recalling firm: Roche Molecular Systems Inc
Product: Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Product code: NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Reason for 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.
Root cause tag: software
FDA root cause: Software design
Action: The cobas MRSA/SA tests has the potential for 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.
Quantity in commerce: 136 kits
Distribution: Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
Product codes and lots: Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1195-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1195-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

Product code NQX

K142721Class IIcobas MRSA/SA TestRoche Molecular Systems, Inc. / cleared 2014-12-17

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)