Drug recall
Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert…
FDA recall event 74803 · Class II · Cepheid
Key facts
| Event ID | 74803 |
|---|---|
| Recall numbers | Z-2548-2016 |
| Recalling firm | Cepheid |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations. |
| Initiation date | Jul 18, 2016 |
| Report date | Aug 24, 2016 |
| Termination date | Sep 30, 2016 |
| City | Sunnyvale |
| State | CA |
| Country | United States |
| FEI number | 3004530258 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: