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Immulite 2000 System - Intact PTH Assay
- Starting date:
- November 23, 2016
- Posting date:
- December 5, 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-61314
Reason
Siemens has confirmed that Immulite 2000/Immulite 2000 XPI Intact PTH Kit Lot 320 can exhibit an average negative bias of up to -39% at intact parathyroid hormone (iPTH) concentrations
Affected products
Immulite 2000 System - Intact PTH Assay
Lot or serial number
320
Model or catalog number
L2KPP2
L2KPP6
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
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