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Immulite 2000 System - SHBG
- Starting date:
- January 31, 2017
- Posting date:
- February 14, 2017
- 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-62204
Reason
Certain lots do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8 degree Celsius, as published in the instructions for use (IFU). After a two week (14 days) period a bias in patient samples may show result in quality control falling outside of established ranges. Identified lots can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 for sex hormone-binding globulin (SHBG) concentration of 5nmol/L to 170nmol/L during the open vial adjustor stability period of 30 days. The bias observed was not concentration dependent.
Affected products
Immulite 2000 System - SHBG
Lot or serial number
357, 358, 360, 361, 363
Model or catalog number
L2KSH2
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM