Recall Z-1243-2016— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-1243-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-13

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2016-01-13, terminated 2018-01-08. It names one FDA 510(k) clearance: K932926. Product: 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 IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders. Reason: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-01-13
Terminated: 2018-01-08
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K932926 — IMMULITE ESTRADIOLDiagnostic Products Corp.·cleared 1994-01-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.