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Immulite Anti-Tg Ab Systems (2017-06-22)
- Starting date:
- June 22, 2017
- Posting date:
- July 11, 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-63898
Affected Products
A. Immulite System - Anti-Tg Ab
B. Immulite 1000 System - Anti-Tg Ab
Reason
Siemens has confirmed that Immulite Systems Anti-TG Ab calibration verification material (CVM), lot 102, levels CVM2 through CVM4, catalog LTGCVM, is recovering high outside of the published +/- 2SD guideline ranges in the IFU. This issue applies to use with the Immulite 2000 and Immulite 2000 XPI Anti-TG AB assay only.
Affected products
A. Immulite System - Anti-Tg Ab
Lot or serial number
102
Model or catalog number
LTGCVM
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
B. Immulite 1000 System - Anti-Tg Ab
Lot or serial number
102
Model or catalog number
LTGCVM
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM