Z-2401-2011

Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48

Name: Z-2401-2011 Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48
Creator: Cepheid
Published: 2011-04-01
License: https://open.fda.gov/license/

Cepheid / initiated 2011-04-01 / Terminated / root cause: software

FDA source

Cepheid began a recall of Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48 on 2011-04-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2401-2011
Status: Terminated
Initiated: 2011-04-01
Posted: 2011-05-31
Terminated: 2011-06-20
Recalling firm: Cepheid
Product: Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48
Product code: NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
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.
Root cause tag: software
FDA root 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.
Product codes and lots: V 4.1a

Product code NJR

K103766Class IIXpert Flu, Genexpert Dx Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 and 4.0Cepheid / cleared 2011-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)