Z-1960-2014Class II

ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack...

Name: Z-1960-2014 ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2013-06-25
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-06-25 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used... on 2013-06-25. FDA classified it as Class II and gives the reason as "ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1960-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-25
Posted: 2014-07-02
Terminated: 2016-05-31
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
Product code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Healthcare sent an Urgent Field Safety Notice that was sent to all affected Siemens Healthcare Diagnostics customers in the United States on June 25, 2013. The Urgent Field Safety Notice was sent out for distribution to all customers outside the United States on June 24, 2013. These notices inform the customer that the 1:10 diluted patient recovery is lower than reported in the Instructions for Use (IFU). Customers should discontinue use of both manual and on board 1:10 dilutions of samples with the ADVIA Centaur HCY assay. Customers can continue to use a manual or on board 1 :2 dilution for samples with results outside of the assay range. Siemens has confirmed the performance at the 1 :2 dilution level meets the IFU ranges. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Technical Solutions Center or your local Siemens technical support representative. For further questions please call (508) 668-5000.
Quantity in commerce: 51 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of : Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Italy Kazakhstan, Latvia, Liechtenstein, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland ,Turkey, Unit.Arab Emir and Vatican
Product codes and lots: Lot #/Exp. Date: 88D1524 01 Jun 2014 88D3303 26 Nov 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1960-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1960-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-02

Product code LPS

K013406Class IIAdvia Centaur Homocysteine AssayBayer Diagnostics Corp. / cleared 2001-12-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)