Immulite System Anti-TG Ab and Immulite 1000 System - Thyroid Autoantibody Assay Anti-TG Ab (2018-04-25)

Starting date:

April 25, 2018

Posting date:

May 11, 2018

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-66732

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  Reason
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  Affected products

Affected products

1. IMMULITE SYSTEM - ANTI-TG AB
2. IMMULITE 1000 SYSTEM - THYROID AUTOANTIBODY ASSAY - ANTI-TG AB

Reason

Siemens healthcare diagnostics has confirmed that the dilutions, some target means and some +/- 2 Standard Deviations (SD) guideline ranges in the Instructions For Use (IFU) for the Immulite Systems Anti-Tg Ab Calibration Verification Material (CVM) lots 101, 102, 103, and 103l are incorrect. Customers using the Immulite Systems Anti-Tg Ab CVM lots 101, 102, 103, and 103l may obtain results outside the published +/- 2 SD guideline ranges listed in their respective IFUs with a valid calibration. The Immulite Anti-Tg Ab quality control material and patient results are not impacted on any of the Immulite Systems.

Affected products