Dimension Chemistry Thyroid Stimulating Hormone Systems

Starting date:

May 15, 2013

Posting date:

June 17, 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-34215

• Reason
• Affected products

Recalled products

1. Dimension Vista System-Thyroid Stimulating Hormone (TSH)
2. Dimension Clinical Chemistry System-Thyroid Stimulating Hormone Assay
3. Dimension Xpand System-Thyroid Stimulating Hormone (TSH) Assay
4. Dimension EXL System-Thyroid Stimulating Hormone 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