Recall Z-1241-2016 ยท CHP Radioimmunoassay, Estradiol
Siemens Healthcare Diagnostics, Inc
Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension VistaSystem. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregna
| Date | Jan 13, 2016 |
| Status | Terminated |
| Reason | The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. |
| Root cause | Device Design |
| Action | Siemens issued an Urgent Medical Device Correction (UMDC) to affected Siemens Healthcare Diagnostics customers in the United States on January 13, 2016 to be delivered to customers on January 14, 2016 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 13, 2016. The letters identified affected product, problem and the actions to be taken. Customers may continue to use the estradiol assays to report patient results however, the assays should not be used for patients being treated with fulvestrant. Cust |
| Quantity | 1945 units |
| Distribution | Worldwide Distribution US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.