Cepheid: Medical Device Recall in 2025 - (Recall #: Z-0414-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: August 6, 2025

Date Posted: November 5, 2025

Recall Number: Z-0414-2026

Event ID: 97497

Reason for Recall:

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

Status: Ongoing

Product Quantity: 4,132 kits

Code Information:

Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Lot Numbers: 27815 27816 Batch Numbers: 1001424179 1001424181

Distribution Pattern:

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

Voluntary or Mandated:

Voluntary: Firm initiated