Recall Z-1243-2016 ยท CHP Radioimmunoassay, Estradiol
Siemens Healthcare Diagnostics, Inc
IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders
| 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 | 9334 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
| K932926 | IMMULITE ESTRADIOL Diagnostic Products Corp., Jan 10, 1994 |