Recall Z-0414-2026— Cepheid

Name: FDA recall Z-0414-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-06

Class II · Ongoing

Class II FDA medical device recall by Cepheid, initiated 2025-08-06. It names 2 FDA 510(k) clearances: K243070, K100822. 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 methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique. Reason: As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type..

Recalling firm: Cepheid
Classification: Class II
Status: Ongoing
Initiated: 2025-08-06
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K243070 — Xpert® SA Nasal CompleteCepheid®·cleared 2024-10-25
K100822 — XPERT MRSA/SA NASAL ASSAYCepheid·cleared 2010-06-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

Data sourced from openFDA. This site is unofficial and independent of the FDA.