Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1195-2018 — Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.

U.S. FDA — Device Enforcement · United States · 2017-10-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1195-2018
Date of alert
2017-10-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Molecular Systems, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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