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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