Advia Centaur and Centaur CP Systems - TSH3-Ultra Assay

Starting date:

May 15, 2013

Posting date:

June 19, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-34243

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  Reason
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  Affected products

Recalled products

1. Advia Centaur System - TSH3-Ultra (TSH3-UL) Assay
2. Advia Centaur CP System- TSH3-Ultra (TSH3-UL) Assay

Reason

Siemens Healthcare Diagnostics is informing customers that a rare variant of TSH, identified in a small cluster of patients, is not detected by the Siemens Assays.  As part of an investigation of unexplained discordant results, samples were identified in which the monoclonal antibody used in the reagent failed to detect the TSH molecule. These individuals may have a previously unrecognized, functionally normal TSH variant. The observed rate of occurrence during a 30-month time period was 0.6 x 10-7.

Affected products