Z-2548-2016Class II

Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert...

Name: Z-2548-2016 Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert...
Creator: Cepheid
Published: 2016-07-18
License: https://open.fda.gov/license/

Cepheid / initiated 2016-07-18 / Terminated / root cause: manufacturing process

FDA source

Cepheid began a recall of 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... on 2016-07-18. FDA classified it as Class II and gives the reason as "Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2548-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-18
Posted: 2016-08-16
Terminated: 2016-09-30
Recalling firm: Cepheid
Product: 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 code: NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Reason for recall: Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Recall letters dated July 18, 2016 were sent to affected customers on July 19, 2016 by Federal Express. Letters advised users of the affected product and asked that any remaining inventory be destroyed.
Quantity in commerce: 68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
Distribution: 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.
Product codes and lots: Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2548-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2548-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-16

Product code NQX

K070462Class IIXpert MrsaCepheid / cleared 2007-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)