Health product recall

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

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

A. IMMULITE SYSTEM - ANTI-TG AB

Lot or serial number
  • 101
  • 102
  • 103
  • 103L
Model or catalog number

LTGCVM

Companies
Manufacturer

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy

Llanberis, Gwynedd

LL55 4EL

UNITED KINGDOM

B. IMMULITE 1000 SYSTEM - THYROID AUTOANTIBODY ASSAY - ANTI-TG AB

Lot or serial number
  • 101
  • 102
  • 103
  • 103L
Model or catalog number

LTGCVM

Companies
Manufacturer

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy

Llanberis, Gwynedd

LL55 4EL

UNITED KINGDOM