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Health product recall

IMMULITE System Assays (2016-04-20)

Starting date:
April 20, 2016
Posting date:
April 29, 2016
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-58170

Affected Products

A. IMMULITE SYSTEM - IGF-1 (INSULIN LIKE GROWTH HORMONE)
B. IMMULITE 1000 SYSTEM - IGF-1 ASSAY

Reason

Manufacturer has determined that it takes 24 minutes of incubation prior to process the samples on the IMMULITE/IMMULITE 1000 System for the patient sample and the pretreatment solution to reach full equilibration when using pretreatment solution (LGFA) lot 055 contained in IGF-I Kit lot 411. If patient samples are run before reaching full equilibration an under-recovery of up to -36% may occur. If the sample is left to incubate for more than 24 minutes prior to testing, no under recovery is observed.

Affected products

A. IMMULITE SYSTEM - IGF-1 (INSULIN LIKE GROWTH HORMONE)

Lot or serial number

411

Model or catalog number

LKGF1

Companies
Manufacturer
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM

B. IMMULITE 1000 SYSTEM - IGF-1 ASSAY

Lot or serial number

411

Model or catalog number

LKGF1

Companies
Manufacturer
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM