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Terminated

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

FDA Recall Z-1195-2018 · Posted None

Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeNQX
Date Initiated2017-10-27
Date Terminated2020-04-27
Product Quantity136 kits

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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