Class 2 Device Recall Xpert Infinity Software

• Date Initiated by Firm: April 01, 2011
• Date Posted: May 31, 2011
• Recall Status: Terminated on June 20, 2011
• Recall Number: Z-2401-2011
• Recall Event ID: 58568
• 510(K)Number: K103766
• Product Classification: 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification - 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 CA 94089-1189
• 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: 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 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 = NJR