Recall Z-2548-2016
Cepheid · initiated July 18, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).
Reason for recall
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
FDA-determined cause: Nonconforming Material/Component
Action taken
Recall letters dated July 18, 2016 were sent to affected customers on July 19, 2016 by Federal Express. Letters advised users of the affected product and asked that any remaining inventory be destroyed.
Details
- Recall number
- Z-2548-2016
- Initiated
- July 18, 2016
- Terminated
- September 30, 2016
- Product code
- NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- Quantity
- 68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
- 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.
- Recalling firm
- Cepheid, Sunnyvale, CA