Recall Z-2548-2016— Cepheid
Class II · Terminated
Class II FDA medical device recall by Cepheid, initiated 2016-07-18, terminated 2016-09-30. It names one FDA 510(k) clearance: K070462. 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..
- Recalling firm
- Cepheid
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-18
- Terminated
- 2016-09-30
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.