Recall Z-1960-2014 ยท LPS Urinary Homocystine (Nonquantitative) Test System
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.
| Date | Jul 2, 2014 (initiated Jun 25, 2013) |
| Status | Terminated |
| 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 dilu |
| 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, Roman |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013406 | ADVIA CENTAUR HOMOCYSTEINE ASSAY Bayer Diagnostics Corp., Dec 18, 2001 |