Recall Z-1960-2014— Siemens Healthcare Diagnostics, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2013-06-25, terminated 2016-05-31. It names one FDA 510(k) clearance: K013406. 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.. 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)..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-25
- Terminated
- 2016-05-31
- Firm location
- East Walpole, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.