Z-1898-2010

Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid...

Name: Z-1898-2010 Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid...
Creator: Cepheid
Published: 2010-04-05
License: https://open.fda.gov/license/

Cepheid / initiated 2010-04-05 / Terminated / root cause: manufacturing process

FDA source

Cepheid began a recall of Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. Medical device, qualitative in vitro... on 2010-04-05. The reason FDA records is "The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1898-2010
Status: Terminated
Initiated: 2010-04-05
Posted: 2010-07-01
Terminated: 2011-05-25
Recalling firm: Cepheid
Product: Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing.
Product code: NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Reason for recall: The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill patients.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Cepheid, issued a technical bulletin to customers on April 5, 2010 and an updated to the April 5 bulletin dated April 9, 2010 instructing them to perform a reflexive repeat test on any blood culture results initially determined as having SA. If further information on this please contact your Cepheid Sales Representative 1-888-336-2743 or www.CEPHEID.COM.
Quantity in commerce: 5,510 units
Distribution: Worldwide distribution: USA and Europe, Taiwan, and Australia.
Product codes and lots: Product codes GXMRSA/SA-BC-10 (lot numbers 00601, 00602, 00603, 00701, 00801, 00901, 00902, 00903, 00904, 01001, 01101, 01102, 01301, 01302) and GXMRSA/SA-BC-CE-10 (lot numbers 01001, 01101, 01301)

Product code NQX

K082140Class IIXpert Mrsa/sa Blood Culture AssayCepheid / cleared 2008-09-29

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)