FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
- Recall number
- Z-1512-2013
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
- Status
- Terminated
- Initiated
- 2013-05-14
- Posted
- 2013-06-06
- Terminated
- 2015-03-05
- Reason
- iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
- Root cause
- No Marketing Application
- Action
- Siemens sent an Urgent Medical Device Correction letter dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions, contact your Siemens Technical Solutions Center or your local Siemens technical support.
- Quantity
- 309 (100 test) kits
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011
- 510(k) numbers
- ["K121981"]
- PMA numbers
- not on file
- Product code
- CEW
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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