Recall Z-1354-2019— Abbott Ireland Diagnostics Division
Class II · Terminated
Class II FDA medical device recall by Abbott Ireland Diagnostics Division, initiated 2019-02-05, terminated 2020-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.. Reason: Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone..
- Recalling firm
- Abbott Ireland Diagnostics Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-05
- Terminated
- 2020-08-21
- Firm location
- Co. Longford, Ireland
Product description
Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.
Reason for recall
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
Data sourced from openFDA. This site is unofficial and independent of the FDA.