Recall Z-1241-2016— 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. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 Vista¿System. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.. 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
Product description
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 Vista¿System. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
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.