Reported Nov 5, 2025 · Ongoing
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test…
Cepheid
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cepheid · 904 E Caribbean Dr · Sunnyvale, CA · 94089-1189
Is this the product you have?
- Xpert SA Nasal Complete Catalog NumberGXSACOMP-10
- UDI-DI code
07332940000158 Xpert SA Nasal Complete kit10
- test kitA 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
- Lot codes and dates
- Catalog NumberGXSACOMP-10
- UDI-DI code07332940000158
- Lot Numbers27815 27816
- Batch Numbers1001424179 1001424181
- Amount recalled
- 4,132 kits
Where it was sold
Why it was recalled
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
This product could cause temporary or reversible health problems — stop using it.
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