Z-1268-2012

Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use in the...

Name: Z-1268-2012 Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use in the...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2012-02-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-02-16 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in... on 2012-02-16. The reason FDA records is "Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%". 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-1268-2012
Status: Terminated
Initiated: 2012-02-16
Posted: 2012-03-21
Terminated: 2013-10-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems The ADVIA Centaur Vitamin D Total (Vit D) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur Vit Assay is intended as an aid in the determination of vitamin D insufficiency. The ADVIA Centaur Vitamin D Diluent 2-pack is used on board the ADVIA Centaur systems to perform automatic and system-performed dilutions fro Vitamin D assay.
Product code: MRG System, Test, Vitamin D
Reason for recall: Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Siemens Healthcare Diagnostics, sent an "Urgent Device Recall Notice" on February 16, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to discontinue using the automatic and system-performed dilution features for Vitamin D; to discontinue the use of ADVIA Centaur VitD Diluent, 2-pack (REF 10494100); to manually dilute samples with values greater than the assay range of 150 ng/mL (375 nmoI/L), using the ADVIA Centaur VitD Diluent, 1 bottle (REF 10632114) as stated in the Vitamin D assay Instructions For Use (IFU); to review the contents of the recall notice with their Laboratory Director and retest the previous sample results generated using system- performed dilutions, and complete and return the confirmation fax-back form via fax to TECHNICAL SOLUTIONS CENTER at (302) 631-7597. If you have any questions or need additional information, please contact your local Technical Support Provider or Distributor or call (508) 668-5000.
Quantity in commerce: 442 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Columbia, China, Denmark, Egypt, and Hong Kong.
Product codes and lots: Lot # 80230 Expiry Date 04 May 2012

Product code MRG

K110586Class IIAdvia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc. / cleared 2011-10-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)