The ARCHITECT Estradiol Kit Intended to measure estradiol — Class II medical device recall Z-1865-2016
Terminated recall by Abbott Laboratories, reported 2016-06-08, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results i
| Recall number | Z-1865-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories, Abbott Park, IL, United States |
| Recall initiated | 2016-03-24 |
| Classified | 2016-05-31 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2018-04-11 |
| Distributed | 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, WY |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HN, HR, HU, ID, IE, IL, IN, IR, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MX, MY, NG, NL, NO, NZ, OM, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 39,346 units |
| Reason classes | potency |
| Lot numbers | 55900UI00, 55900UI01WITH, 55908UI00, 55908UI01, 55941UI00, 57929UI00, 57929UI01, 57931UI00, 57931UI01, 60105UI00, 60105UI01, 61106UI00, 61106UI01, 62263UI00 |
| Expiration dates | 2016-02-10, 2016-04-23, 2016-04-29, 2016-07-16, 2016-07-27, 2016-08-27, 2016-10-02, 2016-11-27 |
Product
The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Reason for recall
Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1865-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.