Recall Z-1865-2016— Abbott Laboratories
Class II · Terminated
Class II FDA medical device recall by Abbott Laboratories, initiated 2016-03-24, terminated 2018-04-11. FDA's recall record names no specific 510(k) clearance for this event. Product: The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.. Reason: Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant..
- Recalling firm
- Abbott Laboratories
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-24
- Terminated
- 2018-04-11
- Firm location
- Abbott Park, IL, United States
Product description
The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Reason for recall
Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
Data sourced from openFDA. This site is unofficial and independent of the FDA.