FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
- Recall number
- Z-1960-2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Product
- ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
- Status
- Terminated
- Initiated
- 2013-06-25
- Posted
- 2014-07-02
- Terminated
- 2016-05-31
- Reason
- ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).
- Root cause
- Device Design
- Action
- Siemens Healthcare sent an Urgent Field Safety Notice that was sent to all affected Siemens Healthcare Diagnostics customers in the United States on June 25, 2013. The Urgent Field Safety Notice was sent out for distribution to all customers outside the United States on June 24, 2013. These notices inform the customer that the 1:10 diluted patient recovery is lower than reported in the Instructions for Use (IFU). Customers should discontinue use of both manual and on board 1:10 dilutions of samples with the ADVIA Centaur HCY assay. Customers can continue to use a manual or on board 1 :2 dilution for samples with results outside of the assay range. Siemens has confirmed the performance at the 1 :2 dilution level meets the IFU ranges. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Technical Solutions Center or your local Siemens technical support representative. For further questions please call (508) 668-5000.
- Quantity
- 51 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of : Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Italy Kazakhstan, Latvia, Liechtenstein, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland ,Turkey, Unit.Arab Emir and Vatican
- Lot, serial or model codes
- Lot #/Exp. Date: 88D1524 01 Jun 2014 88D3303 26 Nov 2013
- 510(k) numbers
- ["K013406"]
- PMA numbers
- not on file
- Product code
- LPS
- 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