Recall Z-1353-2019 ยท CHP Radioimmunoassay, Estradiol
Abbott Ireland Diagnostics Division
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.
| Date | Feb 5, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On February 5, 2019, the firm sent Product Correction Urgent - Immediate Action Required letters to all their consignees which alerted them to the current issue. We recommend that you follow the necessary actions below: Patients treated with Mifepristone should not be tested with the ARCHITECT or Alinity i Estradiol assay for up to two weeks based on information available regarding Mifepristones bioavailability. - Please review this letter with your Medical Director. - If you have forwarded the products listed above to other laboratories, please inform them of this Product Correction and p |
| Quantity | 2,724 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR. AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, KS, MT, NC, ND, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, AND PUERTO RICO, and countries of Albania, Algeria, Angola, Argentina, Australia, Austr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.