Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48
FDA Recall Z-2401-2011 · Posted 2011-05-31
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Recalling FirmCepheid
Recall StatusTerminated
Product CodeNJR
Date Initiated2011-04-01
Date Terminated2011-06-20
Product Quantity16 US, 3 ROW
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA including CA, UT, TX, NJ, FL, NC, CO, IN, VT, MN and the countries of the UK, Denmark and Saudi Arabia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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