FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
- Recall number
- Z-1120-2013
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
- Status
- Terminated
- Initiated
- 2013-03-13
- Posted
- 2013-04-15
- Terminated
- 2015-03-05
- Reason
- Negative bias in patient samples for Vitamin D
- Root cause
- No Marketing Application
- Action
- Siemens Healthcare issued Urgent Medical Device Recall was sent to all affected Siemens Healthcare Diagnostics customers in the United States on March 13th, 2013. This notice informs the customer of the recall and the actions that need to be taken. The Urgent Medical Device Recall instructs customers to discontinue the use of ADVIA Centaur VitD Assay Kit Lots (REF 10491994 and 10631021) and ADVIA Centaur Systems VitD Cal (REF 10493589 and 10630911) released prior to the recalibration of the assay and request replacement lots. This notice also directs customers to review the contents of the recall notice with their laboratory or medical director. A confirmation fax-back form is included to ensure that all customers in the United States have been notified and have complied with the mandatory action.
- Quantity
- 4133
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88767009 4/28/2013 88787009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90253010 6/2/2013 91934010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92396011 8/12/2013 93363011 8/12/2013 95088011 8/12/2013
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MRG
- 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