Z-1195-2018 Class II Terminated
FDA device recall Z-1195-2018 was initiated by Roche Molecular Systems, Inc. on October 27, 2017 and is designated Class II. 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 te… The recall status is terminated (terminated April 27, 2020). Affected quantity: 136 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- October 27, 2017
- Termination Date
- April 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136 kits
Product Description
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
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.
Distribution Pattern
Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
Code Information
Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).