Recall Z-1242-2016— Siemens Healthcare Diagnostics, Inc
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 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various hormonal 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 recordK-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 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various hormonal 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.