FDA Device recall Z-2548-2016
Xpert MRSA Catalog GXMRSA-120, Rev
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of Xpert MRSA Catalog GXMRSA-120, Rev by Cepheid, citing internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2548-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-18 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cepheid |
| Distribution | AZ, CA, CO, DE, FL, GA, IL, IN, MD, ME, MO, MS, NC, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA |
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
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Identifiers
| code_info | Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2548-2016%22
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