Immulite System Estradiol Assay (2020-02-11)
- Starting date:
- February 11, 2020
- Posting date:
- March 6, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72491
Last updated: 2020-03-10
Affected Products
Immulite System Estradiol Assay
Reason
High discordant Estradiol results for some patients have been reported in conjunction with the reported IMMULITE Estradiol Assays. Siemens Healthineers has determined kit lots 501 and above, released in July 2018 for the IMMULITE systems are potentially affected. Siemens investigation indicates that some patient samples could potentially contain an unidentified interferent which is causing an increase in estradiol concentration in the IMMULTE Estradiol Assay. The majority of the complaints received by Siemens are form the United States. Based on available data the issue has been observed only with customer returned patient samples. Quality control materials will not detect this issue. Siemens is actively working to determine the root cause. Siemens has currently suspended shipment of IMMULITE Systems Estradiol assay.
Affected products
Immulite System Estradiol Assay
Lot or serial number
- 501
- 502
- 503
- 504
- 550
- 552
Model or catalog number
LKE21
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM