Terminated

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

FDA Recall Z-1243-2016 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc

Recall StatusTerminated

Product CodeCHP

Date Initiated2016-01-13

Date Terminated2018-01-08

Product Quantity9334 units

Reason for Recall

The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.

Firm 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. Customers where instructed to complete and return the Correction Effectiveness Check attached. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932926IMMULITE ESTRADIOLDiagnostic Products Corp. · 1994-01-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.