Cepheid: Medical Device Recall in 2016 - (Recall #: Z-2548-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization

Product Classification:

Class II

Date Initiated: July 18, 2016

Date Posted: August 24, 2016

Recall Number: Z-2548-2016

Event ID: 74803

Reason for Recall:

Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.

Status: Terminated

Product Quantity: 68 kit for lot 1000037539 and 127 kit s for lot 1000029307.

Code Information:

Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).

Distribution Pattern:

US only: PA, DE, FL, SC, ME, CA, IL, NC, TX, WA, NY, TN, FL, OR, OK, MO, MS, GA, NM, IN, OH, MD, VA, CO, AZ, and NC.

Voluntary or Mandated:

Voluntary: Firm initiated