Recall Z-1240-2016— Siemens Healthcare Diagnostics, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2016-01-13, terminated 2018-01-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.. Reason: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-13
- Terminated
- 2018-01-08
- Firm location
- East Walpole, MA, United States
Product description
Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.
Reason for recall
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.