Health product recall

Immulite System Estradiol Assay (2020-02-11)

Starting date:
February 11, 2020
Posting date:
March 6, 2020
Type of communication:
Medical Device Recall
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Medical Devices
General Public, Healthcare Professionals, Hospitals
Identification number:

Last updated: 2020-03-10

Affected Products

Immulite System Estradiol Assay


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



Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy

Llanberis, Gwynedd

LL55 4EL