Z-1186-2012

ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500 Test kit...

Name: Z-1186-2012 ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500 Test kit...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2008-10-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-10-03 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500 Test kit 06587575 (129502). For in vitro diagnostic use in... on 2008-10-03. The reason FDA records is "Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias". 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-1186-2012
Status: Terminated
Initiated: 2008-10-03
Posted: 2012-03-07
Terminated: 2012-03-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500 Test kit 06587575 (129502). For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in EDTA plasma or serum using the ADVIA Centaur systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.
Product code: CEW Radioimmunoassay, Parathyroid Hormone
Reason for recall: Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens sent an "URGENT FIELD SAFETY NOTICE" dated October 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructed customer to immediately discontinue the use of ADVIA Centaur Intact PTH (iPTH) assay kits that contain intact PTH (iPTH) reagent lot 138. It also recommended that for serum samples analyzed on the ADVIA Centaur CP system, the content of the Urgent Field Safety Notice be discussed with their laboratory director to determine the need to review previous test results, conduct patient follow up, and repeat testing for iPTH results that were less than the upper limit of the reference range, and had a companion calcium result that was elevated or at the upper limit of normal. Additionally, a Completion Notification form was attached for customers to complete and return. Customers should contact their local technical support provider for questions regarding this recall.
Quantity in commerce: 100 Test =5768; 500 Test =1778
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Chile, Columbia, Egypt, Finland, France, Hong Kong, India, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Poland, South Korea, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Uruguay, and Venezuela.
Product codes and lots: 500 Test Kits Kit Lot Number Expiry Date 17436138 15 January 2009 17601138 15 January 2009 19464138 15 January 2009 21240138 15 January 2009 23262138 15 January 2009 100 Test Kits Kit Lot Number Expiry Date 17435138 15 January 2009 18338138 15 January 2009 19929138 15 January 2009 20943138 15 January 2009 21835138 15 January 2009

Product code CEW

K020217Class IAcs:180 and Advia Centaur Ipth ImmunoassayBayer Diagnostics Corp. / cleared 2002-03-15

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)