Z-1119-2008

ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic...

Name: Z-1119-2008 ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic...
Creator: Siemens Medical Solutions Diagnostics
Published: 2008-01-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-01-12 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions Diagnostics began a recall of ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions... on 2008-01-12. The reason FDA records is "Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay". 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-1119-2008
Status: Terminated
Initiated: 2008-01-12
Posted: 2008-05-06
Terminated: 2012-06-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.
Product code: LOL Hepatitis A Test (Antibody And Igm Antibody)
Reason for recall: Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens issued a Urgent Field Safety Notiifcation (078D0709-01) to all Siemens Diagnostics Branches on 1/12/08 for communication to their customers. This Customer Bulletin/Urgent Field Safety Notification advises the customer of the problem and the actions to be taken to mitigate risk. A Confirmation fax-back form is included to ensure that all customers worldwide have been notified and have complied with the mandatory action.
Quantity in commerce: 49,533
Distribution: Worldwide Distribution - USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Chile, Colombia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
Product codes and lots: All lots

Product code LOL

K971418Class IIChiron Diagnostics Automated Chemiluminescence System (Asc) Centaur AnalyzerChiron Diagnostics Corp. / cleared 1997-07-17

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)