Recall Z-1865-2016 ยท CHP Radioimmunoassay, Estradiol
Abbott Laboratories
The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
| Date | Mar 24, 2016 |
| Status | Terminated |
| Reason | Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant. |
| Root cause | Device Design |
| Action | The firm sent a Product Correction letter dated 3/24/2016 to all affected consignees describing the nature of the recall as well as instructions to follow. The necessary actions included the following: Consignees are asked to review the letter with their Medical Director. Patients undergoing Fulvestrant therapy should not be tested with the ARCHITECT Estradiol assay. Complete the Customer Reply Form. If the consignee has forwarded the product listed to other laboratories, a copy of Product Correction letter should be provided to them. The customer is asked to retain the letter for the |
| Quantity | 39,346 units |
| Distribution | Worldwide Distribution -- US, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY; and, the countries of ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.