Nasal test kits recalled after a false negative on a positive sample
Cepheid is recalling 4,132 Xpert SA Nasal Complete kits after post-market half-time stability testing produced a false negative result for a positive sample type.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a false negative can leave a real positive undetected, and no injuries are reported.
Plain-English summary
The Cepheid Xpert SA Nasal Complete 10-test kit, catalog number GXSACOMP-10, is being recalled. The kit is a collection of reagents and associated materials intended for direct qualitative and/or quantitative testing.
As a result of post-market half-time stability testing, a false negative test result was observed for a positive sample type.
The recall covers 4,132 kits carrying UDI-DI 07332940000158, from lot numbers 27815 and 27816. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
A false negative means a positive sample can be reported as negative. Laboratories holding the affected lots should stop using them and follow Cepheid's instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Cepheid
- Category
- Medical Device — Diagnostic test
- Affected units
- 4,132
Distribution
Related recalls
Same manufacturer · Cepheid
See all →- HighLeukemia test kits recalled over inaccurate results with high white cell counts
FDA (Devices) · 2025-12-24
- HighLeukemia test kits recalled in a second lot family over inaccurate results
FDA (Devices) · 2025-12-24
- ModerateTuberculosis test cartridges recalled after failing expected stability criteria
FDA (Devices) · 2025-12-03
- HighCepheid Sample Collection Device May Leak Causing Cross-Contamination Risk
FDA (Devices) · 2024-08-21
- HighCepheid Xpert Xpress Strep A test kits may produce invalid results
FDA (Devices) · 2023-11-08
Same hazard · false negative
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighHologic Aptima HPV assay may produce invalid or false negative results
FDA (Devices) · 2026-03-25
- HighHeparin antibody test kits recalled over a defect producing negative results
FDA (Drugs) · 2026-01-21
Similar recalls
- HighCepheid Xpert Xpress Strep A test kits may produce invalid results
FDA (Devices) · 2023-11-08
- HighCepheid Recalls Xpert CT/NG Tests Due to Temperature Drift Errors
FDA (Devices) · 2018-02-21
- ModerateCepheid Recalls Xpert EV Assay Kits Due to Invalid Test Results
FDA (Devices) · 2017-10-25
- HighLeukemia test kits recalled in a second lot family over inaccurate results
FDA (Devices) · 2025-12-24
- HighLeukemia test kits recalled over inaccurate results with high white cell counts
FDA (Devices) · 2025-12-24
- HighCepheid Recalls Xpert MRSA Diagnostic Kits Due to Performance Issues
FDA (Devices) · 2016-08-24