Roche Molecular Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1195-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 27, 2017

Date Posted: April 4, 2018

Recall Number: Z-1195-2018

Event ID: 79375

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.

Status: Terminated

Product Quantity: 136 kits

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).

Distribution Pattern:

Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.

Voluntary or Mandated:

Voluntary: Firm initiated