Recall Z-1354-2019
Abbott Ireland Diagnostics Division · initiated February 5, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: List Number 07P5020 - ALL LOTS and List Number 07P5030 - ALL LOTS.
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 provide to them a copy of this letter. - Complete the customer reply form. - Please retain this letter for your laboratory records. If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers please contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
Details
- Recall number
- Z-1354-2019
- Initiated
- February 5, 2019
- Terminated
- August 21, 2020
- Product code
- CHP – Radioimmunoassay, Estradiol
- Quantity
- 64,618
- 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, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovi, Brazil, Brunei, Botswana, Canada, Chile…
- Recalling firm
- Abbott Ireland Diagnostics Division, Lisnamuck Co. Longford
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1353-2019 Class II | Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is…Patient results may be falsely elevated. This patient impact only applies to patients currently being… | 02/05/2019Terminated |