Xpert MRSA Catalog GXMRSA-120 — Class II medical device recall Z-2548-2016
Terminated recall by Cepheid, reported 2016-08-24, distributed in AZ, CA, CO, DE, FL, GA, IL, IN…. Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower
| Recall number | Z-2548-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cepheid, Sunnyvale, CA, United States |
| Recall initiated | 2016-07-18 |
| Classified | 2016-08-16 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2016-09-30 |
| Distributed | AZ, CA, CO, DE, FL, GA, IL, IN, MD, ME, MO, MS, NC, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA |
| Lot numbers | 1000037539, 20417, 20419 |
| Model numbers | GXMRSA-120 |
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
Reason for recall
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2548-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.