FDAOctober 27, 2017device
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
roche molecular systemsrocheroche molecular
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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