Device recall: Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System…
Class II FDA enforcement event 74803. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Cepheid started this device recall on 18 Jul 2016. The firm address in the FDA record is in Sunnyvale, CA. FDA put the recall in Class II. FDA event 74803 has 1 product record. The first FDA enforcement report date is 24 Aug 2016. The record gives the status Terminated, with the termination date 30 Sep 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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.
Recalling firm
Cepheid, Sunnyvale, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2548-2016 | 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 | 68 kit for lot 1000037539 and 127 kit s for lot 1000029307. | Class II | Terminated | 24 Aug 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 9
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Nov 2025 | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. | Device | Class II | 1 |
| 30 Oct 2025 | Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 | Device | Class II | 2 |
| 6 Aug 2025 | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit | Device | Class II | 1 |
| 20 Jun 2024 | Cepheid, Sample Collection Device, Part: 900-0370 | Device | Class II | 1 |
| 24 Apr 2023 | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only | Device | Class II | 2 |
| 9 Oct 2017 | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 10000561 | Device | Class II | 1 |
| 15 Sep 2017 | Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (R | Device | Class II | 1 |
| 27 Jul 2015 | Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert C | Device | Class III | 2 |
Official channels
- FDA enforcement report Z-2548-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 74803. https://recallregister.com/fda/ii/74803/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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.
- What quantity of product is in FDA event 74803?
- The FDA record gives this quantity:
68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.