Immulite Products

Starting date:
October 10, 2012
Posting date:
October 29, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-15174

Recalled Products:

  1. Immulite 2000 / 2000 XPI, IGF-1 Assay
  2. Immulite System, IGF-1 Assay
  3. Immulite 1000, IGF-1 Assay

Reason

Siemens has confirmed a negative bias against mean values obtained with the LGCOCM Control lot 0026 level 2 when used with Immulite/Immulite 1000 IGF-1 (LGKF1) kit lots 322 and above. Also confirmed is an increase of mean values obtained with the LGCOCM control lots 0025, 025l, and 0026 when used with Immulite 2000 / Immulite 2000 XPI IGF-1 (L2KGF2) kit lots 486 and 487.

Affected products

A. Immulite 2000 / 2000 XPI, IGF-1 Assay

Lot or serial number

'025L

Model or catalog number

LGCOCM

Companies
Manufacturer
Siemens Healthcare Diagnostics Products Limited

B. Immulite System, IGF-1 Assay

Lot or serial number

'0025

Model or catalog number

LGCOCM

Companies
Manufacturer
Siemens Healthcare Diagnostics Products Limited

C. Immulite 1000, IGF-1 Assay

Lot or serial number

'0026

Model or catalog number

LGCOCM

Companies
Manufacturer
Siemens Healthcare Diagnostics Products Limited