Immulite IGF-1 System Assays - Various

Starting date:
March 7, 2013
Posting date:
March 20, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-26297

Recalled Products

  1. Immulite 2500 System-IGF-1 (Insulin like Growth Hormone ) Assay
  2. Immulite 2000 System-IGF-1 (Insulin like Growth Hormone ) Assay
  3. Immulite System-IGF-1 (Insulin like Growth Hormone ) Assay
  4. Immulite 1000 System-IGF-1 (Insulin like Growth Hormone ) Assay

Reason

Siemens confirmed a negative bias in patient medians of approximately 5 to 20% using the IGF-I Assay as compared to the reference range medians provided in the IGF-I instructions for use (IFU) with kit lots released August 2008 through July 2011.

Affected products

A. Immulite 2500 System-IGF-1 (Insulin like Growth Hormone ) Assay

Lot or serial number
  • Lots 189 to 227
Model or catalog number
  • L5KGF2
Companies
Manufacturer
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM

B. Immulite 2000 System-IGF-1 (Insulin like Growth Hormone ) Assay

Lot or serial number
  • Lots 441 to 492
Model or catalog number
  • L2KGF2
Companies
Manufacturer
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM

C. Immulite System-IGF-1 (Insulin like Growth Hormone ) Assay

Lot or serial number
  • Lots 315 to 335
Model or catalog number
  • LKGF1
Companies
Manufacturer
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM

D. Immulite 1000 System-IGF-1 (Insulin like Growth Hormone ) Assay

Lot or serial number
  • Lots 315 to 335
Model or catalog number
  • LKGF1
Companies
Manufacturer
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM