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U.S. Department of Health and Human Services

Class 2 Device Recall Xpert MRSA

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  Class 2 Device Recall Xpert MRSA see related information
Date Initiated by Firm July 18, 2016
Create Date August 16, 2016
Recall Status1 Terminated 3 on September 30, 2016
Recall Number Z-2548-2016
Recall Event ID 74803
510(K)Number K070462  
Product Classification System, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct sp - Product Code NQX
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
Code Information Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).
Recalling Firm/
Manufacturer		 Cepheid
904 E Caribbean Dr
Sunnyvale CA 94089-1189
For Additional Information Contact Jasopn Affourtit
408-541-4191
Manufacturer 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 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NQX and Original Applicant = CEPHEID
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