Recall Z-1186-2012
Siemens Healthcare Diagnostics, Inc · initiated October 3, 2008
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.
Codes / 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
Reason for recall
Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1186-2012
- Initiated
- October 3, 2008
- Posted by FDA
- March 7, 2012
- Terminated
- March 8, 2012
- Product code
- CEW – Radioimmunoassay, Parathyroid Hormone
- Quantity
- 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA