Cepheid Recalls Xpert MRSA Diagnostic Kits Due to Performance Issues
Cepheid is recalling specific lots of Xpert MRSA diagnostic kits because internal investigations found potential performance issues at lower positive sample concentrations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical diagnostic device with a potential for performance issues that could lead to inaccurate results, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cepheid is recalling specific lots of the Xpert MRSA assay, a qualitative in vitro diagnostic test used to detect Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs. The recall involves 68 kits from lot 1000037539 and 127 kits from lot 1000029307. These products were distributed in the United States to facilities in Pennsylvania, Delaware, Florida, South Carolina, Maine, California, Illinois, North Carolina, Texas, Washington, New York, Tennessee, Oregon, Oklahoma, Missouri, Mississippi, Georgia, New Mexico, Indiana, Ohio, Maryland, Virginia, Colorado, and Arizona.
The recall was initiated after an internal investigation determined that certain lots of the MRSA kits have the potential for performance issues at lower positive sample concentrations. This may affect the accuracy of test results for patients at risk for nasal colonization.
Healthcare facilities and consumers who have these specific lot numbers should stop using the kits and contact Cepheid for further instructions or a replacement.
The recalled product
- 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…
- Manufacturer
- Cepheid
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog number: GXMRSA-120
- Rev. AJ
Distribution
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