FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH
- Recall number
- Z-2409-2012
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in vitro diagnostic use in the quantitative determination of prolactin in serum using the ADVIA Centaur System. ADVIA Centaur Calibrator B: For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur Systems: Digoxin, FSH, TotallgE, LH, LH2, Prolactin, Total hCG, and TSH
- Status
- Terminated
- Initiated
- 2012-08-07
- Posted
- 2012-09-19
- Terminated
- 2014-02-26
- Reason
- ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40
- Root cause
- Nonconforming Material/Component
- Action
- Siemens Healthcare issued an Urgent Field Safety Notice letter dated August 2012 by e-mail to all affected Siemens Healthcare Diagnostics Branch offices on August 7, 2012. Customers were instructed to discontinue using the ADVIA Centaur Calibrator B lots 40 and below following their obtaining Calibrator 8 lot 41 or higher. Customers were asked to complete and fax-back the response form attached.
- Quantity
- 15, 455 kits
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan, Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK.
- Lot, serial or model codes
- US: 2 Pack Ref: 00649625: Lot Numbers/Exp Date: Dec 2, 2012: 78813A30 79982A30 81013A30 82021B30 82767B30 83453C30 85447D30 87319A40 Exp Date:April 9, 2013 85598A40 85708A40 86098A40 87319A40 87979B40 88809B40 89351C40 91750C40 (6 pack) Ref. 00652707: Lot Numbers/Exp Date: Dec 2 2012 79354A30 80802A30 81892B30 82815B30 83741D30 84186A40 Exp. Date April, 8, 2013 85599A40 86191A40 88102B40 89717C40 91383C40 (6 Pack) Ref: 00654254 79714A30 Exp Date Dec 2, 2012 82370A30 84274A30 85512E30 OUS: 2 pack REF: 00650577 78319A29 Exp Dec 2, 2102 78487A29 79024A29 79403A29 79770B29 79981B29 82935B29 85735C29 00654130 Ref: 00654130 (6 pack) 78321A29 Exp Dec 2,2102 79197A29 83314C29
- 510(k) numbers
- ["K904714"]
- PMA numbers
- not on file
- Product code
- CFT
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28