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.
Reported: March 30, 2016 Initiated: January 13, 2016 #Z-1241-2016
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 1945 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.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 1945 units.
Why was this product recalled? ▼
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 30, 2016. Severity: Moderate. Recall number: Z-1241-2016.
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