Immulite Systems - Rapid Thyroid Stimulating Hormone (TSH) Assays

Starting date:

May 15, 2013

Posting date:

July 23, 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-34725

• Reason
• Affected products

Recalled products

1. Immulite System - Rapid TSH Assay
2. Immulite 2000 System - Rapid Thyroid Stimulating Hormone (TSH) Assay
3. Immulite 1000 System - Rapid TSH Assay
4. Immulite System - Third Generation TSH Assay
5. Immulite 2000 System - Third Generation TSH Assay
6. Immulite 1000 System - Third Generation TSH 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