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U.S. Department of Health and Human Services

Class 3 Device Recall Cepheid Xpert MRSA/S Blood Culture

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 Class 3 Recall
Cepheid Xpert MRSA/S Blood Culture
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on January 09, 2012
Recall Number Z-0453-2012
Recall Event ID 60481
Premarket Notification
510(K) Numbers
K082140  K101879 
Product Classification System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen - Product Code NQX
Product Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001;
Code Information Lots affected: 2803 and 3001
Recalling Firm/
Manufacturer
Cepheid
904 E Caribbean Dr
Sunnyvale, California 94089-1189
For Additional Information Contact Judith A Howard
408-541-4191
Manufacturer Reason
for Recall
Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On 11/17/11, Cepheid issued letters via mail to all its direct consignees, informing them of the affected products and providing instructions on the recall.
Quantity in Commerce 1289
Distribution Product was released for distribution in US.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NQX and Original Applicant = CEPHEID
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