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

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  Reason
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  Affected products

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