CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report

Xpert MRSA recalled by Cepheid

Cepheid is recalling Xpert MRSA, distributed in 24 states. The recall was initiated on 18 Jul 2016 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled68 kit for lot 1000037539 and 127 kit s for lot 1000029307.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2548-2016
FDA event ID: 74803
Recalling firm: Cepheid, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 18 Jul 2016
FDA classified: 16 Aug 2016
Reported: 24 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Bacterial Contamination
Device type: Test Kits & Diagnostics

Timeline

18 Jul 2016	Recall initiated by company
16 Aug 2016	Classified by FDA	+29 days
24 Aug 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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.

Arizona California Colorado Delaware Florida Georgia Illinois Indiana Maryland Maine Missouri Mississippi North Carolina New Mexico New York Ohio Oklahoma Oregon Pennsylvania South Carolina

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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