Immulite IGF-1 System Assays - Various (March 13, 2013)

Starting date:
March 13, 2013
Posting date:
March 13, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-26297

Reason

Siemens confirmed a negative bias in patient medians of approximately 5 to 20 percent 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
Not Applicable



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
Not Applicable



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
Not Applicable



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
Not Applicable