Recall Z-1186-2012 ยท CEW Radioimmunoassay, Parathyroid Hormone
Siemens Healthcare Diagnostics, Inc
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, o
| Date | Mar 7, 2012 (initiated Oct 3, 2008) |
| Status | Terminated |
| Reason | Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias |
| 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 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020217 | ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY Bayer Diagnostics Corp., Mar 15, 2002 |