Recall Z-1353-2019— Abbott Ireland Diagnostics Division

Name: FDA recall Z-1353-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-05

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 ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.. 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 ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.

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.