Recall Z-1195-2018 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Roche Molecular Systems, Inc.
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
| Date | Oct 27, 2017 |
| Status | Terminated |
| Reason | 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 | 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 | 136 kits |
| Distribution | Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142721 | cobas MRSA/SA Test Roche Molecular Systems, Inc., Dec 17, 2014 |