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Roche Molecular Systems, Inc. recalls Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Recalled April 4, 2018 · FDA recall Z-1195-2018 · Roche Molecular Systems
Hazard
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. · FDA Class II
Units
136 kits
Sold at
Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
Description
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.
Product
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Manufacturer(s)
Roche Molecular Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →