Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Recalled by Cepheid Due to As a result of Post-Market half-time stability testing,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cepheid directly.
Affected Products
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique
Quantity: 4,132 kits
Why Was This Recalled?
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cepheid
Cepheid has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report