The Recall Desk
HighFDA (Devices)·Z-0414-2026·Announced 2025-11-05

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.

What this means for you

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 from
Manufacturer
Cepheid
Category
Medical Device — Diagnostic test
Hazard
  • false-negative
  • erroneous-results
  • stability-failure
  • diagnostic

Distribution

Distributed nationwide across the United States.

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