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U.S. Department of Health and Human Services

Class 2 Device Recall Xpert Infinity Software

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 Class 2 Recall
Xpert Infinity Software
see related information
Date Posted May 31, 2011
Recall Status1 Terminated on June 20, 2011
Recall Number Z-2401-2011
Recall Event ID 58568
Premarket Notification
510(K) Number
K103766 
Product Classification Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test - Product Code NJR
Product Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48
Code Information V 4.1a
Recalling Firm/
Manufacturer
Cepheid
904 E Caribbean Dr
Sunnyvale, California 94089-1189
Consumer Instructions No consumer action necessary
For Additional Information Contact Russel K. Enns, PhD.
408-400-8230
Manufacturer Reason
for Recall
A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession.
FDA Determined
Cause 2
DESIGN: Software Design
Action Cepheid sent an Corrective Action Notification letter dated April 13, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cepheid recommended customers using 4.1a software on the INFINITY 48 System that is interfaced to a LIS with Host Ordering to make these alterations in operationof the system. After scanning the Patient ID (optional). Sample ID and Cartridge barcode, the host test order information should apear highlighted in the Order Test workspace. Once the highlighted host order information appears select SUBMIT. Warning. If the host test order informaiton is not highlighted, cancel the order by selecting CLOSE. Re scan Patient ID (optional). Sample ID and cartridge barcode and verify highlighted host test order before SUBMIT. Contact Cepheid Technical Support at 888-838-3222 in the US or 33 5 63 82 53 19 outside of the US for any questions regarding this Corrective Action Notice.
Quantity in Commerce 16 US, 3 ROW
Distribution Worldwide Distribution - USA including CA, UT, TX, NJ, FL, NC, CO, IN, VT, MN and the countries of the UK, Denmark and Saudi Arabia.
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 = NJR and Original Applicant = CEPHEID
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