FDAFDA · Food and drugs·Recall number Z-1195-2018
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
Published April 4, 2018 · Recall initiated: October 27, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Molecular Systems, Inc.
- Distributor
- Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
- Lot
- Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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