IMMULITE System and 1000 System - Turbo Intact PTH Assay (2018-03-26)
- Starting date:
- March 26, 2018
- Posting date:
- May 11, 2018
- 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-66718
Affected products
- IMMULITE SYSTEM - TURBO INTACT PTH ASSAY
- IMMULITE 1000 SYSTEM - TURBO INTACT PTH ASSAY
Reason
Siemens Healthcare Diagnostics has confirmed the potential for failed adjustment slopes (Greater than 1.8) for the IMMULITE 1000 Turbo IPTH (LSKPTZ) Assay with the kit lots 246, 247, and 248.
Affected products
A. IMMULITE SYSTEM - TURBO INTACT PTH ASSAY
Lot or serial number
247
Model or catalog number
LSKPTZ
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM
B. IMMULITE 1000 SYSTEM - TURBO INTACT PTH ASSAY
Lot or serial number
247
Model or catalog number
LSKPTZ
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM