IMMULITE, IMMULITE 1000 System-Turbo Intact PTH assay (2019-03-17)
- Starting date:
- March 17, 2019
- Posting date:
- April 5, 2019
- 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-69490
Last updated: 2019-04-05
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 (>1.8) for the IMMULITE / IMMULITE 1000 Turbo iPTH (LSKPTZ) assay with Kit lots of 255 and above. Siemens is currently investigating the root cause of the issue.
Affected products
A. IMMULITE System-Turbo Intact PTH assay
Lot or serial number
- 255 and higher.
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
- 255 and higher.
Model or catalog number
- LSKPTZ
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM