Recall Z-1242-2016
Siemens Healthcare Diagnostics, Inc · initiated January 13, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: All lots
Reason for recall
The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.
FDA-determined cause: Device Design
Action taken
Siemens issued an Urgent Medical Device Correction (UMDC) to affected Siemens Healthcare Diagnostics customers in the United States on January 13, 2016 to be delivered to customers on January 14, 2016 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 13, 2016. The letters identified affected product, problem and the actions to be taken. Customers may continue to use the estradiol assays to report patient results however, the assays should not be used for patients being treated with fulvestrant. Customers where instructed to complete and return the Correction Effectiveness Check attached. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.
Details
- Recall number
- Z-1242-2016
- Initiated
- January 13, 2016
- Terminated
- January 8, 2018
- Product code
- CHP – Radioimmunoassay, Estradiol
- Quantity
- 9251 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1240-2016 Class II | Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889…The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. | 01/13/2016Terminated |
| Z-1241-2016 Class II | Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product…The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. | 01/13/2016Terminated |
| Z-1243-2016 Class II | IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26…The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results. | 01/13/2016Terminated |