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
Reported: March 30, 2016 Initiated: January 13, 2016 #Z-1243-2016
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 9334 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? ▼
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. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 9334 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-1243-2016.
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